葛兰素史克（GSK）获得FDA批准Blensup治疗多发性骨髓瘤

2025-10-24 05:27

The US FDA has granted approval of GSK's (NYSE:GSK) Blenrep (belantamab mafodotin) in combination with Johnson & Johnson's (JNJ) Velcade (bortezomib) and dexamethasone as a second-line therapy for multiple myeloma.
The approval marks the return of Blenrep to the US market after it was ordered removed from the market in 2022 following the failure of a confirmatory trial. It received accelerated approval in 2020.
In July, an FDA advisory committee voted 5-3 against the benefit-risk profile of Blenrep in combination with Velcade and dexamethasone.
Approval was based on results from the phase 3, open-label DREAMM-7 study in patients who had failed on at least one prior therapy.
Blenrep's label includes a Boxed Warning on the risk of ocular (eye) toxicity.
Despite the approval, GSK shares are down ~6% in after-hours trading Thursday.

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