Latest news with #Blenrep
Reuters
a day ago
- Business
- Reuters
US FDA extends review of GSK's blood cancer drug
July 23 (Reuters) - The U.S. Food and Drug Administration has extended its review of GSK's (GSK.L), opens new tab blood cancer drug Blenrep as a combination treatment, the company said on Wednesday. The health regulator has set an action date of October 23 which provides the FDA with time to review additional information provided in support of the application.
Cision Canada
a day 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.
Business Insider
6 days ago
- Business
- Business Insider
GSK price target lowered to 1,290 GBp from 1,355 GBp at Morgan Stanley
Morgan Stanley lowered the firm's price target on GSK (GSK) to 1,290 GBp from 1,355 GBp and keeps an Underweight rating on the shares. The firm updated the company's model for currency moves and reduced Blenrep sales ahead of the Q2 report. Morgan Stanley cut its peak Blenrep sales estimate to GBP 500M from BBP 1.4B citing the 'low probability' of a U.S. approval. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
6 days ago
- Business
- Yahoo
BofA Maintains a Sell Rating on GSK plc (GSK), Sets a PT of p1,510
GSK plc (NYSE:GSK) is one of the best . On July 15, BofA analyst Sachin Jain maintained a Sell rating on GSK plc (NYSE:GSK) and set a price target of p1,510.00. A doctor and a patient discussing a therapy plan that includes pharmaceutical products. The analyst based the rating on factors related to the company's Blenrep drug, stating that the FDA briefing documents highlighted considerable concerns regarding its ocular toxicity and dosing. Issues associated with these factors are central, and the FDA questioned if suitable dosages have been identified, given the poor tolerability seen in trials. The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are especially alarming, as a majority of the patients experienced severe and recurrent ocular events. Jain also noted the limited applicability of trial results to the US markets because of the use of a comparator arm not approved in the US and low enrollment of US patients, resulting in an uncertain risk-reward balance for the drug and warranting a cautious stance. Formerly known as GlaxoSmithKline, GSK plc (NYSE:GSK) is a global healthcare and biopharmaceutical corporation that develops and distributes a range of vaccines, medications, and consumer health items. It is based in the United Kingdom and has over 20 vaccines in its portfolio, positioning it as a leader in vaccines, immunology, and respiratory therapies. The company also develops cancer treatments for multiple myeloma, ovarian cancer, and endometrial cancer in addition to other drugs. While we acknowledge the potential of GSK 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
6 days ago
- Business
- Yahoo
GSK's Blenrep faces setback as FDA cancer committee votes against approval
The US Food and Drug Administration's (FDA's) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK's Blenrep (belantamab mafodotin) just days before the drug's Prescription Drug User Fee Act (PDUFA) date. This marks a significant setback for the UK-based pharma company, which is aiming to regain approval of the therapy after it was pulled from the US market in 2022 due to concerns raised by late-stage trial data. Blenrep was approved under the FDA accelerated approval process in 2020 to treat multiple myeloma (MM). It is an antibody drug conjugate (ADC) that combines a humanised BCMA monoclonal antibody with the cytotoxic agent auristatin F, linked together by a non-cleavable linker. The ODAC committee had a 7–1 split against the combination of Blenrep plus pomalidomide and steroid dexamethasone and a 5-3 split against the combination of Blenrep with bortezomib and dexamethasone. GSK states it remains confident in the benefit/risk profile of Blenrep as a combination therapy and will continue to work closely with the FDA as they complete the review of the drug in patients with relapsed or refractory multiple myeloma (r/r MM). The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date. The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved. Data supporting the drug's approval comes from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) studies. In the studies, many patients 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. Blenrep combinations are approved in r/r MM in the UK and Japan, as well as other markets, including Switzerland, based on the results of DREAMM-8. Applications for approval in the European Union (EU) and China are ongoing, based on the results of the DREAMM-7 study. "GSK's Blenrep faces setback as FDA cancer committee votes against approval" 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
