GSK’s Blenrep makes its comeback, just not yet in the U.S.

The latest hurdle for Blenrep’s comeback in the U.S. isn’t the same lack of efficacy that sank its accelerated approval conversion two years ago. This time, it’s concerns over inadequate dose optimization, suggesting the antibody-drug conjugate could become a poster child for meeting FDA’s dose optimization requirements.

This week, the BCMA-targeting ADC from GSK plc (LSE:GSK; NYSE:GSK), Blenrep belantomab mafodotin, gained approvals for use in second-line combination therapies in Europe and Canada. The approvals mark a new beginning for the drug, which was withdrawn from the U.S. and European markets after failing a confirmatory trial in a late-line treatment setting following its 2020 approvals. It had yet to be approved in Canada...