(Reuters) -The U.S. Food and Drug Administration has approved British drugmaker GSK’s blood cancer drug, Blenrep, in combination with other treatments, the company said on Thursday, paving the way for a relaunch of the drug after three years.
The approval goes against the recommendation of a panel of independent experts, which had voted against the drug in July, citing concerns about risks of eye-related side effects.
Investors are closely watching the decision as a comeback in the U.S. market for Blenrep is expected to increase confidence in GSK’s projected peak sales of more than 3 billion pounds ($4.03 billion) for the drug.
The drug was withdrawn from the market in 2022 after it failed to show that it was better than an existing treatment in a late-stage study.
The FDA approved Blenrep in combinations with other treatments for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Treatment for this hard-to-treat type of cancer often includes targeted therapies and combination of drugs tailored to individual patient needs.
(Reporting by Padmanabhan Ananthan and Mariam Sunny in Bengaluru; Additional reporting by Bhanvi Satija in London and Kamal Choudhury in Bengaluru; Editing by Maju Samuel)
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