FDA delays decision on Dupixent in COPD; Summit makes a bold claim

2024-05-31

BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!

Today, a brief rundown of news from Regeneron, Summit Therapeutics and Verve Therapeutics, as well as updates from Bristol Myers Squibb and Neurocrine Biosciences that you may have missed from this week.

Regeneron and partner Sanofi announced Friday the Food and Drug Administration has delayed by three months an approval decision for their drug Dupixent in chronic obstructive pulmonary disease, or COPD. The companies had previously asked the agency to expand Dupixent’s use to include maintenance treatment for certain adults with uncontrolled COPD. But the FDA requested extra trial data, and therefore extended its review to Sept. 27. The announcement comes the same day as regulators in the EU recommended an approval in COPD. — Delilah Alvarado

Andrew Bellinger, the chief scientific officer of Verve Therapeutics, is stepping down from his role effective June 21, according to a Friday announcement. Bellinger has served as Verve's CSO since 2019 and will move to an advisory role. Troy Lister, currently senior vice president of research and early development, will take Bellinger's place. In a statement on X, Bellinger said “it has been an honor” to serve as the company's first CSO, adding that he felt it was the “right time” for him to move on to other opportunities. — Delilah Alvarado

Summit Therapeutics, a biotechnology company based in Miami, Florida, on Thursday said that a bispecific antibody it’s developing beat Merck & Co.’s Keytruda in a head-to-head study of people with non-small cell lung cancer. According to Summit, its drug, ivonescimab, significantly improved progression-free survival versus Keytruda across clinical subgroups. However, the company did not disclose any data and the trial was conducted solely in China. Regulators in the U.S. have previously sought evidence that single-country trials are reproducible in different demographic groups. — Ned Pagliarulo

Bristol Myers Squibb’s cell therapy Breyanzi won Food and Drug Administration approval Thursday for another type of blood cancer, mantle cell lymphoma, following past approvals in large B cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. In mantle cell, it can now be used when patients progress following two systemic treatments, including one targeted therapy like AstraZeneca’s Calquence. Breyanzi’s approval was based on the TRANSCEND NHL 001 study, in which 85% of people given the therapy saw a reduction in the number of diseased white blood cells, and 68% who saw a complete elimination of detectable diseased cells. Breyanzi recorded sales of $364 million in 2023. — Jonathan Gardner

Kevin Gorman, the founder and longtime leader of Neurocrine Biosciences, is retiring later this year after 16 years as the company’s CEO. He’ll be replaced by Kyle Gano, another Neurocrine veteran who has served as chief business development and strategy officer since 2020. Neurocrine Neurocrine has grown significantly with Gorman at the helm, developing and launching the rare disease drug Ingrezza. — Ned Pagliarulo

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