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Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes

But A Comeback Remains Possible

 
• By Andrew McConaghie

Blenrep’s withdrawal will add to GSK’s blockbuster drought, and hopes of separate trial success for the BCMA-targeting drug in earlier stage myeloma may now be harder to achieve.

US FDA entrance sign
The FDA is now enforcing the accelerated approval commitments more strictly, including requests for withdrawals. • Source: Shutterstock, JHVEPhoto

GSK is to withdraw its multiple myeloma therapy Blenrep (belantamab mafodotin) from the US market following a US Food and Drug Administration request, as the drug has failed to show significant benefits for patients in a confirmatory study.

The request reflects a wider clampdown by the US regulator on drugs given accelerated approvals but which then fail to perform in confirmatory trials, and is a blow to GSK,...

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