(Reuters) -The U.S. Food and Drug Administration’s panel of independent advisers voted on Thursday against approval of GSK’s blood cancer drug Blenrep for use in combination with other treatments.
The panel voted 5-3 against approving Blenrep in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have undergone at least one prior therapy.
Multiple myeloma, the third most common type of blood cancer, is generally considered treatable but not curable.
The panel also voted 7-1 against approving Blenrep in combination with pomalidomide and dexamethasone, citing that the overall benefit-risk profile of the treatment was not favorable for the proposed patient population at the suggested dosage.
Bortezomib, marketed by Johnson & Johnson as Velcade, and pomalidomide, sold by Bristol Myers Squibb as Pomalyst, are established cancer therapies, while dexamethasone is a widely used generic steroid drug.
The FDA had said in briefing documents released on Tuesday that the benefit-risk profile of Blenrep remains unclear, citing concerns about safety, tolerability and appropriate dosages.
(Reporting by Mariam Sunny and Siddhi Mahatole in Bengaluru; Editing by Mohammed Safi Shamsi)
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