GSK Gets CHMP Nod for Blenrep Combos in Multiple Myeloma

GSK plc GSK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma.The CHMP recommended the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone for treating relapsed/refractory multiple myeloma in adult patients who have received at least one prior therapy. The CHMP also recommended the approval of Blenrep in combination with Bristol Myers’ Pomalyst (pomalidomide) plus dexamethasone for the treatment of relapsed/refractory multiple myeloma in adult patients who have received at least one prior therapy, including Revlimid (lenalidomide).The European Commission will now review the CHMP’s opinion, and a decision from the regulatory body is expected in the third quarter of 2025.The positive CHMP opinion for the Blenrep combo was based on data from the III DREAMM-7 and DREAMM-8 studies.Data from both studies showed that treatment with the Blenrep combo led to statistically significant and clinically meaningful improvements in progression-free survival (PFS) versus standard-of-care as well as overall survival versus triplet combinations in relapsed or refractory multiple myeloma patients.The safety and tolerability of Blenrep combinations in both studies were generally consistent with the known profiles of the individual agents.GSK's Stock PerformanceYear to date, shares of GSK have rallied 14.3% against the industry’s decline of 5.5%.Image Source: Zacks Investment ResearchGSK's Blenrep Combo Nearing a Potential Nod in the United StatesGSK’s biologics license application seeking approval for the Blenrep combination therapy to treat relapsed or refractory multiple myeloma is also under review in the United States.A final decision from the FDA is expected on July 23, 2025.Blenrep combinations were approved in the United Kingdom and Japan in April and May 2025, respectively.Besides the United States and the European Union, the Blenrep combinations are also currently under review in China, Canada and Switzerland.We remind investors that in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory multiple myeloma. The study failed to meet its primary endpoint of PFS, thereby failing to meet the FDA’s accelerated approval regulations.Consequently, Blenrep monotherapy as a treatment for relapsed or refractory multiple myeloma was also withdrawn from the EU market.Now that the Blenrep combo has already been approved in Japan and the United Kingdom and is nearing a potential approval in the United States and European Union, GSK hopes to bring the drug back to the market for patients with this dreadful disease.GSK's Zacks Rank & Other Stocks to ConsiderGSK currently carries a Zacks Rank #2 (Buy).Some other top-ranked stocks in the biotech sector are Halozyme Therapeutics HALO, Lexicon Pharmaceuticals LXRX and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Halozyme’s earnings per share have increased from $5.02 to $5.23 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.56 to $6.77. Year to date, shares of HALO have risen 14.1%.HALO’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.60%.In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 10.7%.LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 14.5%.AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.7 Best Stocks for the Next 30 DaysJust released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Halozyme Therapeutics, Inc. (HALO): Free Stock Analysis Report Lexicon Pharmaceuticals, Inc. (LXRX): Free Stock Analysis Report Amarin Corporation PLC (AMRN): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks