Latest news with #JanssenCilag
Yahoo
09-07-2025
- Business
- Yahoo
Johnson & Johnson (JNJ) Applied to the European Medicines Agency to Expand AKEEGA Usage
Johnson & Johnson (NYSE:JNJ) is one of the . On July 3, Janssen-Cilag, a company of Johnson & Johnson (NYSE:JNJ), reported applying to the European Medicines Agency to expand the use of AKEEGA, a drug that combines niraparib and abiraterone acetate. The new application seeks approval for treating adults with metastatic hormone-sensitive prostate cancer who have specific genetic changes called homologous recombination repair gene alterations. While treatments for mHSPC have improved, over 20% of mHSPC patients have HRR gene alterations, including the BRCA1/2 genes. These patients often have worse outcomes and limited treatment options. A smiling baby with an array of baby care products in the foreground. Janssen-Cilag's submission is based on results from the Phase 3 AMPLITUDE study. This study tested niraparib and abiraterone acetate with prednisone or prednisolone versus the current standard treatment. The combination significantly delayed cancer progression and the worsening of symptoms. Johnson & Johnson (NYSE:JNJ) is an international healthcare company that develops and sells medical products. The company operates through two main segments, which include Innovative Medicine and MedTech. While we acknowledge the potential of JNJ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
07-07-2025
- Business
- Yahoo
Johnson & Johnson submits application to the European Medicines Agency seeking indication extension of AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone1 The results demonstrate significant and clinically meaningful benefits of the niraparib and abiraterone acetate plus prednisone or prednisolone regimen in delaying cancer progression and worsening of symptoms1 BEERSE, BELGIUM, July 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of an extension of indication application to the European Medicines Agency (EMA) seeking approval of AKEEGA® (niraparib and abiraterone acetate) with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and homologous recombination repair (HRR) gene alterations. mHSPC is a form of prostate cancer that has spread to other parts of the body, but still responds to hormone therapy.2 While the treatment landscape has advanced in recent years, almost all patients eventually develop resistance to therapy, and the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive and currently incurable disease stage.3 Over 20 percent of patients with mHSPC have HRR gene alterations, including alterations in BRCA1/2, which have been shown to negatively impact outcomes.4 These patients have an unmet medical need which existing therapies do not address.4 'Despite significant progress in prostate cancer, individuals with HRR gene alterations often face limited treatment options, faster onset of symptoms and poorer outcomes,' said Henar Hevia, Ph.D., Senior Director, EMEA Therapy Area Head, Oncology, Johnson & Johnson Innovative Medicine. 'With this submission to the EMA, we have the opportunity to offer patients with HRR-mutated mHSPC a treatment specifically targeted to the underlying biology of their disease. Pending approval, this niraparib-based combination will help redefine the standard of care for this high-risk population, significantly delaying the time to their cancer progressing. This milestone reflects our commitment to advancing precision medicine in earlier stages of disease.' The submission was supported by data from the Phase 3 AMPLITUDE study (NCT04497844), evaluating the efficacy and safety of niraparib and abiraterone acetate plus prednisone or prednisolone (AAP) for the treatment of patients with mHSPC with HRR gene alterations, versus placebo plus AAP.1,5 The study demonstrated clinically meaningful and statistically significant outcomes in the primary endpoint of radiographic progression-free survival (rPFS), and the key secondary endpoint of time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS) – highlighting the clinical benefits of niraparib and abiraterone acetate plus prednisone or prednisolone in delaying both cancer progression and the worsening of symptoms versus the current standard of care.1 AMPLITUDE is the first study to show the efficacy of combining a poly (ADP-ribose) polymerase (PARP) inhibitor and androgen receptor pathway inhibitor (ARPI) in this patient population.1 The safety profile of niraparib and abiraterone acetate plus prednisone or prednisolone is consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which niraparib and abiraterone acetate is currently approved.1,6 The most common Grade 3/4 adverse events (AEs) with the niraparib combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low.1 'At Johnson & Johnson, we remain committed to addressing the needs of individual patients by pushing the boundaries of science and innovation to deliver more personalised and effective treatment options at every stage of the prostate cancer journey,' said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine. 'The fixed dose combination of niraparib and abiraterone acetate has already had a positive impact in shifting the treatment paradigm for patients with metastatic castration-resistant prostate cancer, and we now look forward to extending this benefit to those with hormone-sensitive disease.' Results from the AMPLITUDE study were presented as a late-breaking oral presentation (Abstract #LBA5006) at the 2025 American Society of Clinical Oncology Annual Meeting and selected for inclusion in the Best of ASCO and the ASCO Press Programme.1 About AMPLITUDE AMPLITUDE (NCT04497844) is an ongoing, Phase 3, randomised, double-blind, placebo-controlled, international, multicentre study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual action tablet (DAT) formulation with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate in a DAT formulation with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic hormone-sensitive prostate cancer (mHSPC).5 The primary endpoint is radiographic progression-free survival (rPFS).5 The study enrolled 696 participants from 32 countries.1 About Niraparib and Abiraterone Acetate This orally administered, dual action tablet (DAT) consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.5,7 Niraparib combined with abiraterone acetate and given with prednisone or prednisolone was approved in April 2023 in the European Economic Area for the treatment of patients with BRCA-mutated mCRPC6 in whom chemotherapy is not clinically indicated. Niraparib and abiraterone acetate is also approved in the USA, Canada, Switzerland, United Kingdom and many more. Additional marketing authorisation applications are under review across a number of countries globally. In April 2016, Janssen Biotech, Inc. entered into a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2019), for exclusive rights to niraparib in prostate cancer.8 About Metastatic Hormone-Sensitive Prostate Cancer Metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.2 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of niraparib and abiraterone acetate. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Janssen-Cilag International NV 2025. All rights reserved. ### References Attard G et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. 2025 American Society of Clinical Oncology Annual Meeting. 3 June 2025. National Cancer Institute. Hormone-sensitive prostate cancer. Online. Available at: Last accessed June 2025. Last accessed June 2025. Narayan V et al. Treatment Patterns and Survival Outcomes Among Androgen Receptor Pathway Inhibitor-Experienced Patients With Metastatic Castration-Resistant Prostate Cancer. Clinical Genitourinary Cancer. 2024. 22(6):1-14. Olmos D et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Annals of Oncology. 2025. doi: 10.1016/ A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE). Available at: Last accessed June 2025. Janssen EMEA. Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations. Available at: Last accessed June 2025. AKEEGA Summary of Product Characteristics. August 2024. Available at: Last accessed June 2025. Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer. Available at: Last accessed June 2025. CP-526340 July 2025 CONTACT: Media contact: Laura Coughlan lcoughl5@ +358 87 147 9356 Investor contact: Raychel Kruper investor-relations@ in to access your portfolio
Yahoo
15-06-2025
- Business
- Yahoo
Investigational combination of first-in-class bispecific antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA1 Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs1 BEERSE, BELGIUM, June 15, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, announced today new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY®▼(talquetamab), the first European Commission (EC) approved GPRC5D-directed bispecific antibody, and TECVAYLI®▼(teclistamab), the first EC approved BCMA-directed bispecific antibody. The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD).1 EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group (IMWG) criteria.2 RedirecTT-1 is the largest study dedicated to patients with EMD to date.1 These data were featured in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress.1 EMD represents an aggressive form of multiple myeloma and occurs when myeloma cells spread and form tumours (plasmacytomas) elsewhere in the body, such as in soft tissues and organs.3 These patients often face limited treatment options and worse outcomes due to the complexity of the disease, including tumour heterogeneity, resulting in low ORRs and rapid relapses with current standard therapies.2,3 On average, TCE RRMM patients with EMD have an ORR of less than 40 percent and a median progression-free survival (PFS) of less than six months.4 'The investigational combination of talquetamab and teclistamab has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma, and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short,' said Yael Cohen, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.* 'Dual targeting of GPRC5D and BCMA may lead to a higher ORR and greater depth of response by mitigating target antigen-related escape. The RedirecTT-1 trial shows the power of this novel dual-targeting combination approach as a potential treatment option for patients with this disease.' The Phase 2 RedirecTT-1 study enrolled 90 patients with TCE RRMM with true EMD.1 Of these patients, 84.4 percent were triple-class refractory, 35.6 percent were penta-drug refractory, 20.0 percent had previously received BCMA CAR-T therapy, and 8.9 percent had previously received a bispecific antibody.1 The investigational combination of talquetamab and teclistamab led to a high ORR of 78.9 percent (95 percent confidence interval [CI]; 69.0–86.8), with more than half of patients (54.4 percent) achieving complete response or better.1 High responses were observed even in patients exposed to prior BCMA CAR-T or anti-FcRH5 bispecific antibodies (83.3 percent ORR; 58.6-96.4 and 75.0 percent ORR; 34.9-96.8, respectively).1 Among responders, 66.2 percent remained in response at the data cutoff, with a median follow-up of 13.4 months, signalling deep and durable responses.1 Treatment with the combination resulted in 61.0 percent of patients progression-free and alive at one year.1 Additionally, the combination led to durable responses, with 64.1 percent of patients maintaining response (median duration of response: 13.8 months) and 74.5 percent of patients alive at one year, while median overall survival was not yet reached.1 'Multiple myeloma remains a complex and heterogeneous disease, with extramedullary disease presenting a particularly aggressive and challenging to treat form,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson Innovative Medicine. 'The RedirecTT-1 study reflects our strategy to harness novel mechanisms of action, such as the combination of these dual bispecific antibodies, to help redefine potential outcomes for subsets of patients who are currently faced with a poor prognosis and limited options.' The safety profile of the combination was consistent with previous reports of talquetamab and teclistamab as monotherapies, with no new safety signals identified.1 Patients were given the option to switch to once a month dosing potentially contributing to improved tolerability.1 Rates of discontinuation were low with the treatment combination of talquetamab and teclistamab due to adverse events (AEs).1 Four participants discontinued talquetamab only.1 Reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade.1 Of the ten patients who had Grade 5 AEs (11.1 percent), five were due to infections.1 There were five patient deaths due to infection and the rates of severe infection were similar to those observed with some BCMA bispecific antibody monotherapies.1 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,' said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'Our first-in-class bispecific antibodies talquetamab and teclistamab have transformed treatment for relapsed or refractory multiple myeloma. The RedirecTT-1 study underscores our commitment to advancing innovative therapies that attack the disease in different ways by building combinable and complementary regimens.' About Talquetamab Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.5 The U.S. Food and Drug Administration (FDA) also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.6 Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on the surface of T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors.5 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. About TeclistamabTeclistamab received EC approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.7 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.8 Teclistamab received approval from the U.S. FDA in October 2022 for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.9 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.9,10 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body's immune system to fight the cancer. Teclistamab is currently being evaluated in several combination studies.10,11,12,13,14 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. About Multiple MyelomaMultiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15,16 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.15,16 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.17 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy18,19 while remissions become progressively shorter.18,19,20 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.21 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and talquetamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. * Yael Cohen, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel., has provided consulting, advisory and speaking services to Janssen-Cilag International NV; she has not been paid for any media work. ### 1 Kumar S, et al. Phase 2 study of Talquetamab + Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma with Extramedullary Disease: presentation at 2025 European Hematology Association (EHA) Congress; June 12-15, 2025. 2 Ho M, et Multiple Myeloma: Challenges and Opportunities. Curr. Oncol, 2025; 32: 182. 3 Blade J, et al. Extramedullary Disease in Multiple Myeloma: a Systematic Literature Review. Blood Cancer J, 2022; 12(3):45.4 Moreau P, et al. Outcomes of Patients With Extramedullary Disease in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma From the Pooled LocoMMotion and MoMMent Studies. Clinical Lymphoma, Myeloma and Leukemia, 2025; 25: S2152-2650.5 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: Last accessed: June 2025.6 FDA. FDA Grants Accelerated Approval to Talquetamab-tgvs for Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025.7 Janssen Marks First Approval Worldwide. Available at: Last accessed: June 2025.8 European Commission Approves Reduced Dosing Frequency for Janssen's Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: Last accessed: June 2025.9 U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025. 10 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: Last accessed: June 2025.11 A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: Last accessed: June 2025.12 A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025.13 A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: Last accessed: June 2025.14 A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (TecDara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: Last accessed: June 2025.15 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget 2013;4(12):2186-2207.16 American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: Last accessed: June 2025.17 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: Last accessed: June 2025.18 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.19 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23.20 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.21 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: June 2025. CP-526056 June 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@
Medscape
20-05-2025
- Health
- Medscape
MHRA Approves Guselkumab for Inflammatory Bowel Disease
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya, Janssen-Cilag Limited) for use in adults with Crohn's disease and ulcerative colitis (UC). The drug is already licensed in the UK for plaque psoriasis and psoriatic arthritis. The new indication covers patients with moderately to severely active Crohn's disease or UC who have not responded to other treatments or have experienced unacceptable side effects. Guselkumab is a monoclonal antibody (IgG1-lambda) that inhibits interleukin-23 (IL-23)—a natural cytokine associated with inflammatory and immune responses—by selectively binding to its p19 subunit. This inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release. The European Medicines Agency extended the drug's indications in March. Crohn's Disease: Remission in More Than Half of Patients The MHRA said that clinical trials showed that guselkumab reduced symptoms such as diarrhoea and abdominal pain in patients with Crohn's disease. Three studies involving around 1400 patients found that up to 56% achieved clinical remission after 12 weeks of treatment. In comparison, 15%-22% of patients on placebo reached remission. Endoscopic response, indicating reduced intestinal inflammation, was seen in up to 41% of patients treated with guselkumab versus 11%-21% in the placebo group. A follow up study published last year showed that 57%-75% of patients maintained remission to week 48, depending on the dose. Endoscopic remission at week 48 was reported in 17%-33% of treated patients. Initial induction treatment is given by either intravenous infusion or injection every 4 weeks for three cycles. This is followed by maintenance therapy with subcutaneous injections every 4 or 8 weeks, depending on the induction phase response. Pre-filled syringes or pens are available for self-administration. Ulcerative Colitis: Long-Term Remission Achievable In UC, guselkumab helps to reduce abdominal pain and inflammation of the intestinal lining, reducing fatigue and helping patients maintain normal activities. According to the MHRA, 23% of patients receiving guselkumab achieved clinical remission after 12 weeks of induction treatment, compared with 8% on placebo. With continued treatment, remission was reported in up to 50% of patients by week 44. In the placebo group, the remission rate was 19%. A study extension, presented by the manufacturer at Digestive Disease Week this month, showed 72% of patients in clinical remission, with 99% of them remaining corticosteroid free for 8 or more weeks through to week 92. Among the 43% of trial patients in endoscopic remission at week 44, most (84%) maintained this outcome through to week 92. Induction treatment for UC involves monthly intravenous infusions. Maintenance treatment is delivered by subcutaneous injection. Treatment should be discontinued if there is no clinical response after 24 weeks. Adverse Effects and Safety Monitoring Guselkumab is associated with an increased risk of infections, particularly of the upper respiratory tract. Fungal and viral infections, such as tinea and herpes simplex, are also common. Patients should be screened for tuberculosis before initiating treatment. Live vaccines are contraindicated during therapy. Other commonly reported side effects include headache, injection site reactions, arthralgia, elevated liver enzymes, diarrhoea, and gastroenteritis. Julian Beach, interim executive director of healthcare quality and access at the MHRA, said in a press release: 'We're assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new formulation have been met." He added that the safety of guselkumab will be kept under close review. Healthcare professionals and patients are encouraged to report adverse reactions via the Yellow Card scheme. A full list of side effects will be included in the Patient Information Leaflet and the Summary of Product Characteristics, available on the MHRA website within 7 days of approval.
