(Reuters) -The U.S. Food and Drug Administration has extended its review of GSK’s blood cancer drug Blenrep as a combination treatment, the company said on Wednesday.
The health regulator has set an action date of October 23, which provides the FDA with time to review additional information provided in support of the application.
The company is seeking approval for Blenrep in combination with other treatments for patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
The drugmaker had voluntarily withdrawn the drug from the U.S. market in 2022 after it failed to show it was better than an existing treatment in a late-stage study.
The regulator’s panel of independent experts last week recommended against the drug, citing concerns about previously documented risks of eye-related side effects.
The experts voted 5-3 to say the benefits of Blenrep with bortezomib and dexamethasone at the proposed dosage did not outweigh its risks, and 7-1 against Blenrep in combination with pomalidomide and dexamethasone.
Bortezomib and pomalidomide are approved cancer therapies, while dexamethasone is a widely used generic steroid drug.
GSK said it is confident in the data supporting Blenrep combinations and looked forward to ongoing conversations with the FDA as they continue their review.
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.
Blenrep combinations are currently approved in the UK, Japan, Canada and other countries.
(Reporting by Sneha S K and Sriparna Roy in Bengaluru; Editing by Sriraj Kalluvila and Shailesh Kuber)
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