Latest news with #DREAMM-7
Yahoo
4 days ago
- Business
- Yahoo
GSK's Blenrep combos approved for multiple myeloma in EU
GSK has secured approval in the European Union (EU) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The therapy received approval for use in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) in patients who had received a minimum of one previous therapy, including lenalidomide. The approval was supported by efficacy results from the pivotal DREAMM-7 and DREAMM-8 Phase III trials, which demonstrated clinically meaningful improvements in progression-free survival (PFS) for Blenrep combinations compared to standard triplet therapies in both studies. In DREAMM-7, Blenrep combinations also showed improved overall survival (OS) compared to a daratumumab-based triplet. The tolerability and profiles of the combinations were consistent with the established profiles of the individual components. GSK oncology research and development global head and senior vice-president Hesham Abdullah stated: 'Today's approval of Blenrep combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU. 'Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings.' The combinations also secured approval in relapsed or refractory multiple myeloma in Japan, the UK and other markets, including Switzerland and Canada, based on the findings from DREAMM-8. Meanwhile, the US Food and Drug Administration (FDA) has extended the review period for the biologics licence application (BLA) submitted by the company for Blenrep combinations for the same indication. The new Prescription Drug User Fee Act action date is set for 23 October 2025, allowing the FDA additional time to evaluate the supplementary information provided in support of the BLA. "GSK's Blenrep combos approved for multiple myeloma in EU" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
5 days ago
- Business
- Malaysian Reserve
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma
Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7 Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed1,2,3 First and only approved anti-BCMA-ADC for the treatment of multiple myeloma in Canada MISSISSAUGA, ON, July 23, 2025 /CNW/ – GSK announced today that Health Canada has approved Blenrep (belantamab mafodotin for injection) in combination with bortezomib and dexamethasone, or in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including lenalidomide for the latter combination. Superior efficacy results, when compared to standard of care, from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support the approval of the Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results versus standards of care in both trials and overall survival (OS) in DREAMM-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.2,3 'The approval of Blenrep in Canada represents an advancement for patients with multiple myeloma, a challenging condition marked by repeated cycles of remission and relapse,' said Michelle Horn, Country Medical Head, GSK Canada. 'As the only BCMA-targeted antibody-drug conjugate, Blenrep has been shown to extend survival and remission, supported by data from the DREAMM-7 and DREAMM-8 phase III clinical trials. This approval marks a milestone in offering a treatment option that holds the promise to transform the therapeutic approach for patients facing their first or subsequent relapses.' Blenrep is the first and only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) for multiple myeloma, providing patients facing their first and subsequent relapses with a differentiated mechanism of action. Blenrep combinations can be administered to a broad range of patient types without complex pre-administration regimens or hospitalization. 'As patients with multiple myeloma receive combination therapies at diagnosis, the availability of diverse treatment options like Blenrep is vital for prolonging remission and enhancing survival outcomes,' said Martine Elias, Chief Executive Officer of Myeloma Canada. 'This milestone represents a transformative step forward in the treatment landscape, empowering our community and reinforcing our commitment to making myeloma matter while driving progress toward a cure.' In the DREAMM-7 and DREAMM-8 clinical trials, Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.2,3 The most common adverse reactions, occurring in ≥20% of patients, were reduced visual acuity (BCVA), corneal examination findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, eye pain, cataract, upper respiratory tract infection, pneumonia, fatigue, thrombocytopenia, diarrhea, and peripheral sensory neuropathy. Eye-related side effects, a known side effect of treatment with Blenrep, were manageable with extended time between infusions and dose reductions, while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials.2,3 About multiple myelomaMultiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.7 Multiple myeloma is a significant concern in Canada, where in 2024 alone, 4,000 people were diagnosed with the disease.8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.1 About Blenrep Blenrep is an ADC comprising a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. In Canada, Blenrep (belantamab mafodotin for injection) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Specifically, Blenrep is indicated: in combination with bortezomib and dexamethasone (BVd), in adult patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone (BPd), in adult patients who have received at least one prior line of therapy, including lenalidomide. Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. About DREAMM-7DREAMM-7 is a multicentre, open-label, randomized phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in adult patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy. The trial enrolled 494 participants who were randomized 1:1 to receive either BVd or DVd for eight cycles, after which patients received belantamab mafodotin or daratumumab as a monotherapy. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity. Other secondary endpoints include overall response rate (ORR), safety, and patient-reported quality-of-life outcomes. The Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS. The median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with BVd compared to 13.4 months (11.1-17.5) with DVd (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). For Overall Survival (OS), at the first pre-planned interim analysis, the hazard ratio was 0.57; 95% CI, 0.40, 0.80, indicating a 43% reduction in the risk of death in favour of BVd. More recently, the updated OS results were statistically significant and maintained the reduction in the risk of death in favour of BVd. These results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.2,4 These findings were consistently observed in subgroups and supported by secondary endpoints. About DREAMM-8DREAMM-8 is a multicentre, open-label, randomized phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in adult patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The trial included 302 participants who were randomized 1:1 to receive either BPd or PVd. Patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 81% were refractory to lenalidomide, 25% had prior anti-CD38 exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient-reported quality-of-life outcomes. In DREAMM-8, the Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS, with a 48% reduction in the risk of disease progression or death compared to PVd (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001). At the primary analysis, with a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with BPd compared to 12.7 months (95% CI: 9.1-18.5) for PVd. Recently, in an updated interim analysis, after a median follow-up of 28.01 months, the mPFS in the BPd arm was 32.6 months compared with 12.5 months in the PVd arm. These results were presented at the European Hematology Association (EHA) Annual Meeting in June 2025.9 The clinical benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics. GSK in OncologyOur ambition in oncology is to help increase overall quality of life, maximise survival, and change the course of disease, expanding from our current focus on blood and women's cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the 'Risk Factors' section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. References _______________________ 1 Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20). doi:10.1182/blood-2014-11-568923. 2 Hungria V, Robak P, Hus M et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933. 3 Dimopoulos MA, Beksac M, Pour L, Delimpasi S et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. PMID: 38828951. 4 Hungria V, Robak P, H Marek et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. December 2024 5 Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660. 6 Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676– 10.1053/ 7 Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available at: Accessed 5 March 2025. 8 Multiple myeloma statistics. Canadian Cancer Society. Available at: Accessed 11 July 2025. 9 UPDATED RESULTS FROM PHASE 3 DREAMM-8 STUDY OF BELANTAMAB MAFODOTIN… – Dimopoulos M – EHA-3268 – Jun 13 2025, Available at:
Cision Canada
6 days ago
- Business
- Cision Canada
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma Français
Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7 Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed 1,2,3 First and only approved anti-BCMA-ADC for the treatment of multiple myeloma in Canada MISSISSAUGA, ON, July 23, 2025 /CNW/ - GSK announced today that Health Canada has approved Blenrep (belantamab mafodotin for injection) in combination with bortezomib and dexamethasone, or in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including lenalidomide for the latter combination. Superior efficacy results, when compared to standard of care, from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support the approval of the Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results versus standards of care in both trials and overall survival (OS) in DREAMM-7. 2, 3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents. 2, 3 "The approval of Blenrep in Canada represents an advancement for patients with multiple myeloma, a challenging condition marked by repeated cycles of remission and relapse," said Michelle Horn, Country Medical Head, GSK Canada. "As the only BCMA-targeted antibody-drug conjugate, Blenrep has been shown to extend survival and remission, supported by data from the DREAMM-7 and DREAMM-8 phase III clinical trials. This approval marks a milestone in offering a treatment option that holds the promise to transform the therapeutic approach for patients facing their first or subsequent relapses." Blenrep is the first and only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) for multiple myeloma, providing patients facing their first and subsequent relapses with a differentiated mechanism of action. Blenrep combinations can be administered to a broad range of patient types without complex pre-administration regimens or hospitalization. "As patients with multiple myeloma receive combination therapies at diagnosis, the availability of diverse treatment options like Blenrep is vital for prolonging remission and enhancing survival outcomes," said Martine Elias, Chief Executive Officer of Myeloma Canada. "This milestone represents a transformative step forward in the treatment landscape, empowering our community and reinforcing our commitment to making myeloma matter while driving progress toward a cure." In the DREAMM-7 and DREAMM-8 clinical trials, Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators. 2, 3 The most common adverse reactions, occurring in ≥20% of patients, were reduced visual acuity (BCVA), corneal examination findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, eye pain, cataract, upper respiratory tract infection, pneumonia, fatigue, thrombocytopenia, diarrhea, and peripheral sensory neuropathy. Eye-related side effects, a known side effect of treatment with Blenrep, were manageable with extended time between infusions and dose reductions, while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials. 2,3 About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 7 Multiple myeloma is a significant concern in Canada, where in 2024 alone, 4,000 people were diagnosed with the disease. 8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 1 About Blenrep Blenrep is an ADC comprising a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. In Canada, Blenrep (belantamab mafodotin for injection) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Specifically, Blenrep is indicated: in combination with bortezomib and dexamethasone (BVd), in adult patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone (BPd), in adult patients who have received at least one prior line of therapy, including lenalidomide. Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. About DREAMM-7 DREAMM-7 is a multicentre, open-label, randomized phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in adult patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy. The trial enrolled 494 participants who were randomized 1:1 to receive either BVd or DVd for eight cycles, after which patients received belantamab mafodotin or daratumumab as a monotherapy. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity. Other secondary endpoints include overall response rate (ORR), safety, and patient-reported quality-of-life outcomes. The Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS. The median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with BVd compared to 13.4 months (11.1-17.5) with DVd (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). For Overall Survival (OS), at the first pre-planned interim analysis, the hazard ratio was 0.57; 95% CI, 0.40, 0.80, indicating a 43% reduction in the risk of death in favour of BVd. More recently, the updated OS results were statistically significant and maintained the reduction in the risk of death in favour of BVd. These results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024. 2,4 These findings were consistently observed in subgroups and supported by secondary endpoints. About DREAMM-8 DREAMM-8 is a multicentre, open-label, randomized phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in adult patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The trial included 302 participants who were randomized 1:1 to receive either BPd or PVd. Patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 81% were refractory to lenalidomide, 25% had prior anti-CD38 exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient-reported quality-of-life outcomes. In DREAMM-8, the Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS, with a 48% reduction in the risk of disease progression or death compared to PVd (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001). At the primary analysis, with a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with BPd compared to 12.7 months (95% CI: 9.1-18.5) for PVd. Recently, in an updated interim analysis, after a median follow-up of 28.01 months, the mPFS in the BPd arm was 32.6 months compared with 12.5 months in the PVd arm. These results were presented at the European Hematology Association (EHA) Annual Meeting in June 2025. 9 The clinical benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics. GSK in Oncology Our ambition in oncology is to help increase overall quality of life, maximise survival, and change the course of disease, expanding from our current focus on blood and women's cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. SOURCE GlaxoSmithKline Inc.
Yahoo
17-07-2025
- Business
- Yahoo
GSK's Blenrep US comeback hindered by eye safety concerns
GSK's plan to bring blood cancer drug Blenrep (belantamab mafodotin) back to markets has hit a stumbling block, after the US Food and Drug Administration (FDA) identified eye safety concerns ahead of a meeting to discuss the therapy's benefit-risk ratio. FDA reviewers flagged high rates of ocular toxicity, including corneal disease, known as keratopathy, and visual acuity changes. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July. Shares in London-listed GSK closed 1.19% down to a price of £1,402.5 following the document release compared to the market open on 15 July. Prices had not recovered by the market open on 16 July. The British drugmaker has a market cap of £57bn. The briefing document was published ahead of an Oncologic Drugs Advisory Committee (ODAC) on 17 July that will review data for Blenrep's safety and effectiveness. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved. FDA reviewers wrote: 'While ocular adverse events have been seen with other antibody-drug conjugates used for the treatment of cancer, this toxicity is unique among therapies for the treatment of multiple myeloma.' The key trials supporting the drug's approval are the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) studies. FDA reviewers said the majority of patients in these trials experienced keratopathy and Visual Acuity (KVA) events. All grade KVAs occurred in 92% and 93% of patients in DREAMM-7 and DREAMM-8, respectively, while more serious grade 3-4 events were found in 77% and 78% of patients in the same two studies. GSK is looking to get Blenrep FDA-approved in combination with Takeda's Velcade and dexamethasone to treat adults with multiple myeloma who have already tried one prior line of therapy. The drugmaker is also seeking a positive decision for the antibody-drug conjugate (ADC) used in combo with Bristol Myers Squibb's Pomalyst and dexamethasone in the same proposed patient group. Blenrep originally won FDA approval in 2020 to treat multiple myeloma. Although initially getting ahead in the now lucrative ADC market, GSK pulled the drug in 2022 after confirmatory trial shortcomings. Since then, GSK has been busy conducting trials to showcase Blenrep's effectiveness in treating the rare type of blood cancer. In its own briefing document, the British big pharma company said that results from DREAMM-7 and DREAMM-8 'consistently demonstrated meaningful benefit across endpoints and supported the positive benefit-risk of Blenrep'. Data from the studies were enough to convince the European equivalent of the ODAC – the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Blenrep in May 2025. However, the European Commission (EC) has not yet decided whether to approve the drug. The UK was the first country to authorise Blenrep in the revised treatment setting in April 2025. Buoyed by momentum in the wider ADC market, GSK has forecast more than £3bn in peak annual sales for Blenrep. Estimates by GlobalData – which go as far as 2031 – predict peak sales of $1.9bn. How ODAC votes will be a key factor in whether this sales figure is reached, however. While other ADCs are known for their side effects, a snag for GSK is that Blenrep seems to be the sole product in which eye safety has been a concern. "GSK's Blenrep US comeback hindered by eye safety concerns" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-04-2025
- Business
- Yahoo
UK's MHRA authorises GSK's Blenrep for multiple myeloma treatment
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorised GSK's Blenrep for treating multiple myeloma (MM). This authorisation is said to be a global first for Blenrep in this treatment setting. Blenrep, in conjunction with bortezomib and dexamethasone (BVd) is approved for adults who have previously undergone a minimum of one therapy. Additionally, it is approved as the combination with pomalidomide and dexamethasone (BPd) for those who have previously been treated with lenalidomide, among other therapies. The MHRA decision is supported by efficacy outcomes from the Phase III DREAMM-7 and DREAMM-8 trials in relapsed or refractory MM, which demonstrated meaningful progression-free survival (PFS) and overall survival (OS) results. The tolerability and safety profiles of the Blenrep combos align with those of the individual agents involved. Its combos are being reviewed in 14 nations, including the US, Japan, the European Union, China, Switzerland, and Canada. GSK oncology, research and development (R&D) global head and senior vice-president Hesham Abdullah said: 'Today's approval of Blenrep combinations in the UK is a transformative milestone for patients with MM, a cancer marked by remission and relapse. 'As the only B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate (ADC) therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.' Blenrep consists of an ADC that features a humanised antibody targeting BCMA, attached to the toxic compound auristatin F through a stable linker. The technology for the drug-linker combination is obtained under license from Seagen, while the production of the monoclonal antibody leverages POTELLIGENT Technology licensed from Kyowa Kirin Group's BioWa. As the only anti-BCMA ADC in MM, the therapy could be administered in various oncology treatment settings. Last month, GSK announced that it is partnering with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to explore if its shingles vaccine, Shingrix, could minimise the dementia risk. "UK's MHRA authorises GSK's Blenrep for multiple myeloma treatment" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
