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LONDON - The U.S. Food and Drug Administration has extended its review period for GSK’s (NYSE:GSK) Blenrep combinations for the treatment of relapsed or refractory multiple myeloma, pushing the decision date to October 23, 2025, the company announced Wednesday.
The extension provides the FDA with additional time to review supplemental information provided in support of the Biologics License Application for Blenrep (belantamab mafodotin-blmf) in patients who have received at least one prior line of therapy.
The application is supported by data from two phase III clinical trials, DREAMM-7 and DREAMM-8, which showed statistically significant progression-free survival results for Blenrep combinations versus standard of care treatments. The DREAMM-7 trial also demonstrated overall survival benefits versus a daratumumab-based triplet therapy.
GSK stated that the safety and tolerability profiles of the Blenrep combinations were consistent with the known profiles of the individual agents.
Blenrep combinations have already received regulatory approvals in the UK, Japan, Canada, Switzerland, and the United Arab Emirates. Applications are under review in other major markets including the European Union and China.
Multiple myeloma is the third most common blood cancer globally with approximately 180,000 new cases diagnosed each year. The disease is generally considered treatable but not curable, according to information provided in the company’s press release statement.
Blenrep is an antibody-drug conjugate that targets B-cell maturation antigen (BCMA), a protein expressed on multiple myeloma cells.
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