What's Happening?
GSK has secured FDA approval for its multiple myeloma drug Blenrep (belantamab mafodotin) to return to the U.S. market as a third-line treatment. This approval comes three years after the drug was removed
from sale. Blenrep is now approved in combination with Velcade (bortezomib) and dexamethasone, but not with Pomalyst (pomalidomide) due to concerns about ocular toxicity. The drug's use is restricted to third-line settings, unlike in other markets where it is approved for second-line use.
Why It's Important?
The re-approval of Blenrep is a significant development for GSK, as it aims to regain market share in the competitive multiple myeloma treatment landscape. The narrower label, however, limits its potential market impact in the U.S., a key market for pharmaceutical sales. The decision reflects the FDA's cautious approach to balancing drug efficacy with safety concerns, particularly regarding ocular toxicity. For patients, Blenrep offers an additional treatment option, potentially improving outcomes in a challenging disease.
What's Next?
GSK will focus on expanding Blenrep's use into first-line settings, with ongoing trials like DREAMM-10. The company aims to demonstrate the drug's efficacy in newly diagnosed, transplant-ineligible multiple myeloma patients. The success of these trials will be critical for achieving GSK's sales targets and expanding Blenrep's market presence. The company will also monitor the drug's performance in the U.S. market closely, given the competitive landscape and the impact of its restricted label.
