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GSK Says US FDA Committee Votes Against Blood Cancer Drug's Benefit-Risk Profile; Shares Down Pre-Bell
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GSK Says US FDA Committee Votes Against Blood Cancer Drug's Benefit-Risk Profile; Shares Down Pre-Bell
Jul 18, 2025 2:30 AM

05:13 AM EDT, 07/18/2025 (MT Newswires) -- GSK (GSK) said Thursday the US Food and Drug Administration's oncologic drugs advisory committee voted against the benefit-risk profile of Blenrep combinations at the proposed dosage for adults with relapsed or refractory multiple myeloma.

The company's shares were down more than 1% in premarket activity Friday.

The FDA will consider the panel's recommendation ahead of the July 23 action date, the company said.

GSK remains positive on Blenrep's profile and intends to work closely with the agency during its review, it said

Blenrep combinations are already approved in the UK, Japan and Switzerland, and are under review in the EU and China, the company said.

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