GSK submitted the same Blenrep clinical trial data to global regulators and the FDA, but received a slightly more limited regulatory approval in the U.S. In an interview during the annual meeting of the American Society of Hematology, GSK oncology executive Hesham Abdullah explained what else the FDA wants from Blenrep clinical trials.
GSK drug Blenrep, which exited the market in 2022 after failing a confirmatory study, now has a new FDA approval as a third-line multiple myeloma treatment. The U.S. regulatory decision is more limited than the recent European approval for the blood cancer drug.
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Results from the Phase 3 DREAMM-7 study show GSK drug Blenrep is helping multiple myeloma patients live longer compared to treatment with blockbuster Johnson & Johnson drug Darzalex. The data, presented Monday during the annual meeting of the American Society of Hematology, are part of a submission now under FDA review that could lead to Blenrep’s return to the market.
GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.
GSK took Blenrep off the market last year after the multiple myeloma drug failed its confirmatory study. But GSK now says it has interim data showing Blenrep beat a blockbuster Johnson & Johnson drug in a head-to-head Phase 3 study testing it as an earlier line of therapy.
Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
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