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Cision Canada
a day ago
- Health
- Cision Canada
Health Canada expands approval of Scemblix®, making it an option for newly diagnosed and previously treated chronic myeloid leukemia (CML) patients Français
Scemblix ® is first to show superior efficacy and a favourable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies 1,2 Fifty percent of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue or switch therapies within one year of treatments 2 Scemblix ®, a new first-line option for adults with CML, is now approved for newly diagnosed and previously treated CML MONTREAL, July 30, 2025 /CNW/ - Novartis Canada is pleased to announce that Health Canada has granted a Notice of Compliance for Scemblix ® (asciminib tablets) for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who are newly diagnosed or who have previously received one or more tyrosine kinase inhibitors (TKIs). 1 In Canada, Scemblix ® was previously approved for the treatment of adult patients with Ph+ CML-CP previously treated with two or more TKIs. Newly diagnosed patients will now have access to a treatment that has shown superior efficacy versus all standard of care (SoC) therapies and a favourable safety and tolerability profile. "The approval of a new treatment option for newly diagnosed and previously treated Canadians living with CML is an important milestone," said Lisa Machado, founder, Canadian CML Network. "As a person living with CML and an advocate, I am hopeful that expanded access to this innovative treatment option will offer patients not only continued positive outcomes, but also provide the opportunity to maintain a quality of life that meets their expectations as they and their families navigate the complexities of CML management." CML that is diagnosed in the chronic phase has a more favourable prognosis than CML that is diagnosed in the accelerated or blast phase. Although the Ph chromosome is present in everyone with CML, in rare cases it can't be found during testing. In general, Ph+ CML has a more favourable prognosis than Ph- CML. 3 While TKIs have transformed CML into a chronic disease, efficacy, safety and tolerability challenges continue to hinder long-term treatment success for many patients. Many patients do not meet molecular response goals, and many discontinue or change treatment due to intolerance. 4,5,6 "The approval of asciminib represents a significant step forward, expanding treatment options for CML patients," said Dr. Dennis Kim, Professor of Medicine, Princess Margaret Cancer Centre. "Having a diverse range of therapies available allows care teams to keep the unique needs of the patient at the centre of treatment plans, optimizing outcomes. The ability to prescribe asciminib to newly diagnosed and previously treated patients offers a promising new pathway in our efforts to manage this complex disease effectively and safely." "We are proud that Health Canada has expanded its approval of Scemblix ®, making it a new option for all Canadians with chronic myeloid leukemia, whether they are newly diagnosed or have been previously treated," said Mark Vineis, Country President, Novartis Canada. "This approval means patients and their physicians now have more choices when deciding on the best course of treatment, offering renewed hope for individuals living with CML, their families, and the healthcare teams dedicated to their care." The clinical effectiveness, safety and cost-effectiveness of Scemblix ® is currently under review by Canada's Drug Agency (CDA) and Institut National d'Excellence en Santé et Services Sociaux (INESSS). Novartis looks forward to communicating their recommendations with the CML community, when available. About Chronic Myeloid Leukemia (CML) Chronic myeloid leukemia (CML) is a type of cancer that develops in the blood-forming cells of the bone marrow. In 95% of patients with CML, a genetic mutation produces an abnormal chromosome in bone marrow stem cells known as the Philadelphia chromosome ("Ph chromosome"). When the Ph chromosome is present, CML is classified as Philadelphia chromosome-positive (Ph+). 7 The Ph chromosome produces the BCR-ABL1 protein, which causes bone marrow to make too many abnormal white blood cells. These cells overcrowd healthy blood cells, which can be fatal if untreated. 7 CML has three stages: chronic, accelerated, and blast phases. Most patients are diagnosed in the chronic phase, and with proper treatment, can often stay in this early stage without advancing further. 7 According to the most recently available data, 665 Canadians were diagnosed with CML in 2019 and 140 Canadians died from CML in 2022. 8 About Scemblix ® (asciminib tablets) Scemblix ® is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature). 9,10 The current approved CML treatments are TKIs that target the adenosine triphosphate (ATP)-binding site (ATP-competitive). 10 About the ASC4FIRST Trial The approval of Scemblix ® is based on results from the ongoing Phase III ASC4FIRST trial in patients newly diagnosed with Ph+ CML-CP. 1 Data has shown: Nearly 20% more patients treated with Scemblix ® achieved MMR versus investigator-selected (IS) SoC TKIs (imatinib, nilotinib, dasatinib and bosutinib) (68% vs. 49%, p < 0.001) and nearly 30% more patients achieved MMR versus imatinib alone (69% vs. 40%, p < 0.001) at week 48. 1,2 Scemblix ® is the first CML treatment to show superior efficacy along with a favourable safety and tolerability profile verus imatinib and second generation TKIs. 1,2 In newly diagnosed Ph+ CML-CP patients, the most common adverse reaction (≥ 20%) was musculoskeletal pain. Serious adverse events occurred in 11% of patients who received Scemblix ®. Serious adverse reactions in ≥ 1% included pancreatitis (1%). 1, 2 About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit SCEMBLIX ® is a registered trademark. SOURCE Novartis Pharmaceuticals Canada Inc.
Yahoo
18-06-2025
- Health
- Yahoo
Health Canada approves Novartis' KISQALI® for HR+/HER2- early breast cancer patients at high risk of recurrence
Despite endocrine therapy (ET), the risk of recurrence for people diagnosed with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early breast cancer (eBC) remains high, in addition to the possibility of an incurable metastatic relapse.1 Health Canada approval is based on the pivotal Phase III NATALEE trial data, which demonstrated a clinically meaningful invasive disease-free survival (iDFS) benefit for KISQALI® plus adjuvant aromatase inhibitor (AI) in patients with stage II or III HR+/HER2- eBC.2 KISQALI is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival in three Phase III trials in advanced breast cancer.3,4,5 MONTREAL, June 18, 2025 /CNW/ - Novartis Canada is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for KISQALI® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II-III early breast cancer (eBC) at high risk of recurrence.2 Breast cancer is one of the most common cancers globally,6 with HR+/HER2- being the most prevalent subtype, accounting for approximately 70% of cases.7,8,9 Over 40% of HR+/HER2- breast cancer cases are diagnosed at stage II or III, with a high risk of recurrence for up to 20 years.8,9 If cancer recurs, it is often metastatic which in most cases is considered incurable.10,11 This progression significantly increases the burden on patients, caregivers, and healthcare systems, both financially and emotionally.11,12 On average, 15 Canadian women will die from breast cancer every day.13 "Over our years supporting younger patients, we've seen far too many with HR+ breast cancer become metastatic even while on maintenance endocrine therapy," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer. "Breast cancer is often more aggressive in younger patients, and they have higher rates of recurrence despite early treatment. So, we were thrilled to see that the positive results for KISQALI for early breast cancer are the same for patients of all ages, regardless of stage and nodal status. Our community desperately wants more effective tools to help improve their chances against this challenging disease that's turned their life plans upside-down. This Health Canada approval is an exciting step forward." The Health Canada approval is based on the global Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III eBC. At the final analysis, this clinical trial demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence with ribociclib plus AI compared to AI alone. Among patients with stage II and stage III eBC, ribociclib added to AI demonstrated a 25.1% relative reduction in the risk of an invasive disease-free survival (iDFS) event compared with AI alone,1 with a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial.2,4,14,15 "In the NATALEE trial, ribociclib demonstrated significant efficacy for a broad population of patients with early breast cancer,"2 said Dr. Stephen Chia, Medical Oncologist, BC Cancer and Steering Committee member of the NATALEE trial. "This approval provides a new and expanded treatment option for these patients to help reduce their risk of cancer returning. Patients deserve access to the most effective treatment options, and their individual needs should always be at the centre of shared decision making. In every situation, it's critical to have an open, balanced risk-benefit discussion, in order to make the appropriate treatment decision that's best suited for the patient to reduce the risk of their cancer returning." "While the risk of cancer returning peaks in the first five years after diagnosis, more than half of recurrences occur after this period, and the majority are metastatic and incurable,"16,17 said Dr. Katarzyna Jerzak, Medical Oncologist, Sunnybrook Health Sciences Centre. "Ribociclib provides a new treatment option to help reduce the risk of recurrence and improve outcomes, particularly for patients at elevated risk. This approval expands our treatment arsenal with a targeted therapy that will have a meaningful impact on improving the care of patients diagnosed with early breast cancer in Canada." "Novartis has been advancing innovative research and medical practice in breast cancer care for over 35 years, developing one of the most comprehensive pipelines in the field. Over 100,000 people with HR+/HER2- metastatic breast cancer have been treated with KISQALI globally,18 and now we're focused on expanding its use to those with stage II or III HR+/HER2- early breast cancer to reduce risk of recurrence," said Mark Vineis, Country President, Novartis Canada. "We are actively committed to working with our health system partners to ensure timely access to KISQALI and supporting Canadians and healthcare professionals to improve health outcomes." About early breast cancer (eBC)Breast cancer is the most commonly diagnosed cancer among Canadian women, with approximately 70% of cases diagnosed in the early stages of the disease.7,8,11 However, despite existing treatment options, people with stage II and III HR+/HER2- eBC remain at significant risk of recurrence.11,12 The risk of recurrence is influenced by factors such as lymph node involvement, tumor size, age at diagnosis, and biomarkers. While patients without lymph node involvement typically have a lower risk, nearly 25% of those with HR+/HER2- eBC may experience recurrence within 20 years,1 peaking after the first five years.19 However, more than half of recurrences still happen after five years and more than 80% of these cases are metastatic and incurable.20 About KISQALI® (ribociclib tablets)KISQALI was previously approved by Health Canada on March 2, 2018, for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer.20 KISQALI is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.2 In eBC, KISQALI is the only CDK4/6 inhibitor recommended for both all node-positive disease and patients with no nodal involvement with high-risk disease characteristics.20,21 The National Comprehensive Cancer Network (NCCN) guidelines recommend ribociclib (KISQALI) as a Category 1 preferred CDK4/6 inhibitor for breast cancer patients.21 KISQALI, in combination with an AI, has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment of adults with stage II and III HR+/HER2- eBC, at high risk of recurrence.22 The most common Adverse Drug Reactions across the NATALEE study (>20% and exceeding the frequency for AI alone) were neutropenia (62.5% vs. 4.6%), infections (36.3% vs. 26.3%), nausea (23.3% vs.7.8%, headache (23.0% vs. 17.1%), fatigue (22.3% vs. 13.2%), leukopenia (22.3% vs. 3.6%), and abnormal liver function tests (22.3% vs. 7.6%).2 Please see the Product Monograph for KISQALI, available at About NATALEENATALEE is a global Phase III multi-centre, randomized, open-label trial to evaluate the efficacy and safety of KISQALI with an AI as an investigational adjuvant treatment versus AI alone in patients with stage II and III HR+/HER2- eBC. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin, if applicable. The primary endpoint of NATALEE was invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria. A total of 5,101 adult patients with HR+/HER2- eBC across 20 countries were randomized in the trial.13,23 About NovartisNovartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit References ________________________________1 Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years (incl. supplementary appendix). N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830 2 Novartis. (2025). KISQALI Product Monograph. Accessed June 2025. 3 Hortobagyi G, Stroyakovskiy D. Yardley DA, et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial. Presented at: San Antonio Breast Cancer Symposium 2023 on December 5–9, 2023 San Antonio, TX. 4 Bardia A, Hortobagyi GN, Lipatov O, et al. LBA23: Invasive disease–free survival (iDFS) across key subgroups from the Phase III NATALEE study of ribociclib (RIB) + a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC). Presented at: European Society for Medical Oncology (ESMO) Congress on 23 October 2023. Madrid, Spain. 5 Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer: primary results from the Phase III NATALEE trial. Presented at: the American Society of Clinical Oncology Annual Meeting on June 2, 2023. Chicago, USA. 6 International Agency for Research on Cancer (IARC). Accessed April 2025. 7 American Cancer Society. Breast Cancer Facts & Figures 2019-2020. 2019. Accessed April 2025. 8 Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055. doi:10.1093/jnci/dju055 9 Criscitiello C, Spurden D, Piercy J, et al. Health-Related Quality of Life Among Patients With HR+/HER2- Early Breast Cancer. Clin Ther. 2021;43(7):1228-1244.e4. doi:10.1016/ 10 Mayo Clinic. Recurrent breast cancer. July 2, 2022. Accessed April 2025. 11 Breast Cancer Now. Breast cancer recurrence. May 2019. Accessed April 2025. 12 FDA Approval. Available from Accessed April 2025 13 Government of Canada. Breast cancer in Canada. Accessed June 2025. 14 Slamon D et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024;390:1080-1091. doi: 10.1056/NEJMoa2305488 15 Yardley D, Untch M, et al. Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC) in NATALEE. Presented at the American Society of Clinical Oncology Annual Meeting; May 31, 2024; Chicago, USA. 16 Geurts YM, Witteveen A, Bretveld R, et al. Patterns and predictors of first and subsequent recurrence in women with early breast cancer. Breast Cancer Res Treat. 2017;165(3):709-720. doi:10.1007/s10549-017-4340-3 17 Wangchinda P, Ithimakin S. Factors that predict recurrence later than 5 years after initial treatment in operable breast cancer. World J Surg Oncol. 2016;14(1):223. Published 2016 Aug 24. doi:10.1186/s12957-016-0988-0 18 Novartis Data on File. 19 Bushnell GG, Deshmukh AP, den Hollander P, et al. Breast cancer dormancy: need for clinically relevant models to address current gaps in knowledge. NPJ Breast Cancer. 2021;7(1):66. Published 2021 May 28. doi:10.1038/s41523-021-00269-x 20 Health Canada Approval. Available from Accessed April 2025 21 NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Accessed May 2025. 22 European Society of Medical Oncology (ESMO). ESMO MCBS scorecards; NATALEE. Available at Accessed April 2025. 23 NCT03701334. A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/ HER2- Early Breast Cancer (NATALEE). Updated October 10, 2024. Available at Accessed April 2025 SOURCE Novartis Pharmaceuticals Canada Inc. 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Cision Canada
18-06-2025
- Health
- Cision Canada
Health Canada approves Novartis' KISQALI® for HR+/HER2- early breast cancer patients at high risk of recurrence Français
Despite endocrine therapy (ET), the risk of recurrence for people diagnosed with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early breast cancer (eBC) remains high, in addition to the possibility of an incurable metastatic relapse. 1 Health Canada approval is based on the pivotal Phase III NATALEE trial data, which demonstrated a clinically meaningful invasive disease-free survival (iDFS) benefit for KISQALI ® plus adjuvant aromatase inhibitor (AI) in patients with stage II or III HR+/HER2- eBC. 2 KISQALI is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival in three Phase III trials in advanced breast cancer. 3,4,5 MONTREAL, June 18, 2025 /CNW/ - Novartis Canada is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for KISQALI ® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II-III early breast cancer (eBC) at high risk of recurrence. 2 Breast cancer is one of the most common cancers globally, 6 with HR+/HER2- being the most prevalent subtype, accounting for approximately 70% of cases. 7,8,9 Over 40% of HR+/HER2- breast cancer cases are diagnosed at stage II or III, with a high risk of recurrence for up to 20 years.8, 9 If cancer recurs, it is often metastatic which in most cases is considered incurable. 10,11 This progression significantly increases the burden on patients, caregivers, and healthcare systems, both financially and emotionally. 11,12 On average, 15 Canadian women will die from breast cancer every day. 13 "Over our years supporting younger patients, we've seen far too many with HR+ breast cancer become metastatic even while on maintenance endocrine therapy," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer. "Breast cancer is often more aggressive in younger patients, and they have higher rates of recurrence despite early treatment. So, we were thrilled to see that the positive results for KISQALI for early breast cancer are the same for patients of all ages, regardless of stage and nodal status. Our community desperately wants more effective tools to help improve their chances against this challenging disease that's turned their life plans upside-down. This Health Canada approval is an exciting step forward." The Health Canada approval is based on the global Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III eBC. At the final analysis, this clinical trial demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence with ribociclib plus AI compared to AI alone. Among patients with stage II and stage III eBC, ribociclib added to AI demonstrated a 25.1% relative reduction in the risk of an invasive disease-free survival (iDFS) event compared with AI alone, 1 with a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial. 2,4,14,15 "In the NATALEE trial, ribociclib demonstrated significant efficacy for a broad population of patients with early breast cancer," 2 said Dr. Stephen Chia, Medical Oncologist, BC Cancer and Steering Committee member of the NATALEE trial. "This approval provides a new and expanded treatment option for these patients to help reduce their risk of cancer returning. Patients deserve access to the most effective treatment options, and their individual needs should always be at the centre of shared decision making. In every situation, it's critical to have an open, balanced risk-benefit discussion, in order to make the appropriate treatment decision that's best suited for the patient to reduce the risk of their cancer returning." "While the risk of cancer returning peaks in the first five years after diagnosis, more than half of recurrences occur after this period, and the majority are metastatic and incurable," 16,17 said Dr. Katarzyna Jerzak, Medical Oncologist, Sunnybrook Health Sciences Centre. "Ribociclib provides a new treatment option to help reduce the risk of recurrence and improve outcomes, particularly for patients at elevated risk. This approval expands our treatment arsenal with a targeted therapy that will have a meaningful impact on improving the care of patients diagnosed with early breast cancer in Canada." "Novartis has been advancing innovative research and medical practice in breast cancer care for over 35 years, developing one of the most comprehensive pipelines in the field. Over 100,000 people with HR+/HER2- metastatic breast cancer have been treated with KISQALI globally, 18 and now we're focused on expanding its use to those with stage II or III HR+/HER2- early breast cancer to reduce risk of recurrence," said Mark Vineis, Country President, Novartis Canada. "We are actively committed to working with our health system partners to ensure timely access to KISQALI and supporting Canadians and healthcare professionals to improve health outcomes." About early breast cancer (eBC) Breast cancer is the most commonly diagnosed cancer among Canadian women, with approximately 70% of cases diagnosed in the early stages of the disease. 7,8,11 However, despite existing treatment options, people with stage II and III HR+/HER2- eBC remain at significant risk of recurrence. 11,12 The risk of recurrence is influenced by factors such as lymph node involvement, tumor size, age at diagnosis, and biomarkers. While patients without lymph node involvement typically have a lower risk, nearly 25% of those with HR+/HER2- eBC may experience recurrence within 20 years, 1 peaking after the first five years. 19 However, more than half of recurrences still happen after five years and more than 80% of these cases are metastatic and incurable. 20 About KISQALI ® (ribociclib tablets) KISQALI was previously approved by Health Canada on March 2, 2018, for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer. 20 KISQALI is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. 2 In eBC, KISQALI is the only CDK4/6 inhibitor recommended for both all node-positive disease and patients with no nodal involvement with high-risk disease characteristics. 20,21 The National Comprehensive Cancer Network (NCCN) guidelines recommend ribociclib (KISQALI) as a Category 1 preferred CDK4/6 inhibitor for breast cancer patients. 21 KISQALI, in combination with an AI, has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment of adults with stage II and III HR+/HER2- eBC, at high risk of recurrence. 22 The most common Adverse Drug Reactions across the NATALEE study (>20% and exceeding the frequency for AI alone) were neutropenia (62.5% vs. 4.6%), infections (36.3% vs. 26.3%), nausea (23.3% vs.7.8%, headache (23.0% vs. 17.1%), fatigue (22.3% vs. 13.2%), leukopenia (22.3% vs. 3.6%), and abnormal liver function tests (22.3% vs. 7.6%). 2 Please see the Product Monograph for KISQALI, available at About NATALEE NATALEE is a global Phase III multi-centre, randomized, open-label trial to evaluate the efficacy and safety of KISQALI with an AI as an investigational adjuvant treatment versus AI alone in patients with stage II and III HR+/HER2- eBC. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin, if applicable. The primary endpoint of NATALEE was invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria. A total of 5,101 adult patients with HR+/HER2- eBC across 20 countries were randomized in the trial. 13,23 About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit SOURCE Novartis Pharmaceuticals Canada Inc.
Cision Canada
10-06-2025
- Health
- Cision Canada
The Novartis Oncology Young Canadian Investigator Awards (NOYCIA) returns for its 22nd year at ASCO 2025 Français
For over two decades, NOYCIA has fueled emerging research in Canada, driving scientific knowledge in cancer MONTREAL, June 10, 2025 /CNW/ - Novartis Canada is pleased to announce the winners of the 2025 Novartis Oncology Young Canadian Investigator Awards (NOYCIA), an annual national competition dedicated to advancing oncology through the promotion of research by supporting Canadian oncology researchers. This year marks the 22nd year of the awards, which took place on Sunday, June 1st at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. NOYCIA celebrates the innovative work by selecting ten oncology researchers from Canada who have had their abstracts accepted at ASCO and demonstrate excellence in their area of study. "At Novartis, we are deeply committed to advancing scientific knowledge through innovation and collaboration," said Sophia Kajla, Chief Scientific Officer and Vice-President, Scientific Affairs, Novartis Canada. "The NOYCIA Awards remain at the forefront of supporting innovative cancer research in Canada, reflecting Novartis Canada's ongoing commitment to advancing science and improving patient outcomes. We are proud to continue celebrating and investing in early-career oncology leaders who are pushing the boundaries of discovery and clinical impact." Following deliberation by NOYCIA's Scientific Panel, this year's award recipients were selected for their pioneering research, spanning a range of disciplines, from immune checkpoint inhibitors and immunotherapy to healthcare systems and health human resource planning: The 2025 NOYCIA recipients are: Immune Checkpoint Inhibitors and Immunotherapy: Luciana Siqueira, Princess Margaret Cancer Centre Abstract: The association between emotional distress prior to receiving immune checkpoint inhibitors and overall survival among patients with cancer: A population-based study Supervisors: Dr. Lawson Eng & Dr. Marcus Butler Edmond Rafie, Research Center of the Centre Hospitalier de l'Université de Montréal Abstract: Dietary compounds and patterns associated with immune checkpoint inhibitors (ICI) outcomes in advanced non-small cell lung cancer (NSCLC) Supervisor: Dr. Arielle Elkrief Patrick Tuan Hoang, University of Toronto Abstract: Identification of immunotherapy early treatment failure in non-small cell lung cancer (NSCLC) using a novel cell-free DNA (cfDNA) tissue-agnostic genome-wide methylome enrichment assay Supervisor: Dr. Adrian Sacher Gregoire Marret, University Health Network Abstract: Spatial transcriptomics analysis to predict response to immune checkpoint blockade (ICB) in recurrent or metastatic head and neck squamous cell cancer (RM-HNSCC) Supervisor: Dr. Lilian Siu Rami Habib, McGill University Abstract: JAK inhibitor for the treatment of steroid refractory and life threatening immune-related adverse events secondary to immune checkpoint inhibitors Supervisor: Dr. Khashayar Esfahani Transcriptomics and Molecular Analysis: Xin Wang, Princess Margaret Cancer Centre Abstract: Correlative and spatial transcriptomic analysis of olaparib and durvalumab in patients with recurrent/refractory IDH-mutant gliomas Supervisor: Dr. Eric Chen Ronan McLaughlin, Princess Margaret Cancer Centre Abstract: NeoPancONE: GATA6 Expression as a Predictor of benefit to Peri-Operative Modified FOLFIRINOX in Resectable Pancreatic Adenocarcinoma (r-PDAC): A Multicentre Phase II study Supervisor: Dr. Jennifer Knox Patient Experience and Decision-Making: Rena Seeger, University of Ottawa Abstract: Exploring decisional needs of patients considering first line treatment of Advanced EGFR+ lung cancer: An interpretive descriptive study Supervisor: Dr. Paul Wheatley-Price Novel Therapeutic Approaches: Asli Munzur, University of British Columbia Abstract: Clonal hematopoiesis (CH) in participants with metastatic castration-resistant prostate cancer (mCRPC) receiving 177Lu-PSMA-617 or cabazitaxel: an exploratory post-hoc analysis of a randomized phase II trial (TheraP ANZUP 1603) Supervisor: Dr. Alex Wyatt Healthcare Systems and Workforce Planning: Philip Ding, University of Alberta Abstract: Rethinking future workforce planning by developing novel metrics of complexity in cancer care Supervisor: Dr. Winson Cheung "For over two decades, NOYCIA has been outstanding in encouraging and promoting Canadian-based cancer research, moving scientific knowledge and understanding in oncology forward through the endorsement of research," said Dr. Paul Wheatley-Price, NOYCIA Chair and medical oncologist, The Ottawa Hospital. "The calibre of research occurring in Canada is truly world-class, and the NOYCIA Awards provides the platform to recognize the tremendous contributions of our emerging leaders. It's incredibly rewarding to be part of this initiative and a privilege to continue to serve as the Chair of the Scientific Panel." In addition to recognizing the achievement and potential of scientific investigation, Dr. David Addiss, 2025 NOYCIA guest speaker and Director, Focus Area for Compassion and Ethics (FACE), Task Force for Global Health, encouraged the award recipients and other attendees to cultivate compassion, which is fundamental to the unique relationship between patients and their healthcare providers. "As clinicians and oncology researchers, you are motivated and sustained by compassion—the desire to alleviate and prevent suffering—which arises from a sense of shared humanity," said Dr. Addiss. "And although science shows that compassionate health care provides significant benefits for patients, providers and health systems, we face growing challenges of resource scarcity, time pressures, and other systemic constraints, which may limit our ability to fully realize this ideal in practice. Despite these challenges, connecting with and nurturing our compassionate impulse on a daily basis allows us to accompany and support our patients in a way that enhances both patient satisfaction and professional fulfillment." Mentorship Matters Program NOYCIA 2025 includes the Mentorship Matters Program which offers mentorship opportunities to trainees who attend the NOYCIA awards dinner. The program provides trainees with the opportunity to network with leaders in Canadian cancer centres. Canadian oncologists co-host a table during the NOYCIA awards allowing trainees from across Canada to have the opportunity to hear from mentors about career paths, programs and opportunities that their centres provide and to ask questions. About the Novartis Oncology Young Investigators Award (NOYCIA) With a mission to support Canadian oncology researchers, NOYCIA provides funding, support, and recognition to 10 researchers that demonstrate excellence in their specialist field of study. Eligible applicants include Post-Doctoral Students, Residents, Fellows, Graduate Students, Medical Students, PhD Candidates and Undergraduates who are affiliated with a Canadian institution and are the first author of an abstract accepted for the annual ASCO meeting. For more information about NOYCIA, go to: About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit
Cision Canada
14-05-2025
- Health
- Cision Canada
Novartis Canada extends Health Equity Initiative effort, fueling innovation and impact for second year Français
MONTREAL, May 14, 2025 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis Canada) is pleased to announce the launch of the second edition Health Equity Initiative. Aimed at promoting equitable healthcare for Canadians by addressing health disparities, Novartis Canada will award $500,000 to non-profit projects focused on improving health equity and addressing the unique healthcare challenges faced by underserved and marginalized populations. According to the World Health Organization, health equity is achieved when everyone can attain their full potential for health and well-being. i However, despite having a universal healthcare system, Canada ranks third to last with respect to equity in healthcare access and experience among nine peer countries, highlighting persistent challenges faced by underserved communities. ii The 2025 Health Equity Initiative aims to address Canada's existing healthcare access inequity by supporting individuals and organizations that are fully immersed in their communities, understand their unique needs, and are dedicated to advancing fair access to healthcare. By empowering these agents of change, Novartis seeks to inspire broader community engagement and action to improve healthcare outcomes. Sustaining the momentum from the inaugural Health Equity Initiative in 2024, Novartis will be awarding additional grants to support Canadian non-profit and/or charitable organizations that are pioneering innovative solutions towards equitable healthcare. "We are incredibly proud to continue our commitment to supporting health equity in Canada by launching the second year of this Initiative," said Mark Vineis, Country President, Novartis Canada. "All Canadians deserve equitable access to healthcare and Novartis believes in the power of supporting sustainable, grassroots projects that help advance health equity for underserved communities." In total, more than 130 applications for funding were received in the Initiative's first year. The 2024 winners were selected through a thorough evaluation process designed in collaboration with Equity Mobilizing Partnerships in Community (EMPaCT), each exemplifying the spirit and impact of the Initiative through their innovative approaches to addressing and improving health equity: Black Physicians of Canada: By creating a national database of Black physicians across Canada, this project is to tackling health disparities and improving access to culturally sensitive care, ensuring that Black patients receive health services that acknowledge and respect their unique needs. The development of a Black health digital hub further enhances connectivity and resource sharing among healthcare providers and patients. Foundations for Social Change: This project addresses the health equity challenges faced by those transitioning out of homelessness and extreme poverty in Vancouver by implementing a comprehensive support system – including mental health services, healthcare navigation support and direct cash transfers – to empower individuals with the tools and resources needed to improve health outcomes. Fort Severn First Nation: The northernmost community in Ontario, this project focuses on bridging the healthcare access gap for First Nations communities. By establishing a team of community health coordinators known as Payukotayno Meno ya win, the initiative ensures timely diagnosis and treatment, as well as access to preventative care. These efforts promote greater engagement between families and the healthcare system, fostering trust and improving overall health outcomes within the community. "The Health Equity Initiative's 2024 winners have set a powerful precedent, showcasing the impact of a community-based focus on innovation and collaboration," says Vineis. "Novartis Canada recognizes the importance of supporting community organizations and is committed to supporting all future winners in their missions to drive meaningful action." How to apply for funding Canadian non-profit and/charitable organizations that are passionate about advancing health equity and committed to creating a more inclusive healthcare system are encouraged to learn more and apply for funding by visiting The deadline for applications is 11:59 p.m. PT on June 16, 2025 About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit SOURCE Novartis Pharmaceuticals Canada Inc.
