Multiple myeloma drug Blenreb to be withdrawn from FDA

GSK “Additional late-stage clinical trials in progress… Results expected in the first half of next year”

GlaxoSmithKline (GSK), a large British pharmaceutical company, announced on the 22nd (local time) that it has decided to withdraw its drug ‘Blenrep’ from the US market at the request of the US Food and Drug Administration (FDA). This is due to the fact that the results of phase 3 clinical trials of the treatment did not meet the requirements of the FDA’s accelerated approval regulation.

Blenreb was approved by the FDA in 2020 as an antibody-drug conjugate (ADC). It is also the first approved B-cell maturation antigen (BCMA)-targeted therapy. Since then, several BCMA-targeted therapies for myeloma have emerged, including Bristol-Myers Squibb’s (BMS) CAR-T therapy and the Johnson & Johnson-Legend Biotech partnership.

“We respect the FDA’s decision,” said GSK Chief Medical Officer Sabine Luik. Multiple myeloma is a difficult disease, and patients who develop resistance to standard treatment have a poor prognosis. “As the company continues its clinical trial program, it will work with the FDA to explore important treatment options for patients with multiple myeloma.”

Results from additional phase 3 clinical trials are expected in the first half of next year. In the existing phase 3 trial, monotherapy failed and led to market withdrawal, but two late-stage clinical studies (DREAMM-7 and DREAMM-8) are being tested with combination therapy.

The industry believes that GSK will have to go through an official approval process even if it obtains successful data in future research due to the withdrawal from the market, foreign media such as Pierpharma of the United States reported.

GSK said it is confident that meaningful results will be obtained from the Blendrep combination trial. It has already tested BLENREP along with standard therapies in an early treatment line and obtained positive results. Earlier this month, GSK also limited the indications for Zejula, a second-line maintenance treatment for ovarian cancer.

Meanwhile, starting with the withdrawal of Blenrep, the FDA is expected to decide on expedited approval withdrawal sooner than before if medical data are not met or clinical trials fail. It is said that discussions are continuing to promote rapid drug withdrawal through recent annual meetings.

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