US FDA mulls broader Jemperli label under Priority Review

25 April 2024

The UK’s second-largest drugmaker, GSK (LSE: GSK), expects to hear by the end of August whether the US regulator will expand the label for Jemperli (dostarlimab).

The US Food and Drug Administration will conduct its review of the firm’s supplemental Biologics License Application under the Priority Review scheme, and has set a date of August 23 for its decision.

GSK wants to market the monoclonal antibody, in combination with chemo, for all adults with primary advanced or recurrent endometrial cancer.

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