FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

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The MAA for the Blenrep combo was supported by interim results from the phase III DREAMM-7 and DREAMM-8 studies, both of which met their primary endpoints of progression-free survival (PFS).

The FDA accepted a BLA for Blenrep combinations for multiple myeloma treatment after prior therapy. DREAMM-7 and DREAMM-8 trials showed significant improvements in progression-free survival and ...

GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...

The combinations are also approved for relapsed or refractory multiple myeloma in Japan, the UK and other markets including ...