FDA Delays Dupixent Decision in COPD; Summit's Bold Claim

BioPharma Dive has introduced a new format to provide concise updates on industry developments. This week, key updates come from Regeneron, Summit Therapeutics, Verve Therapeutics, Bristol Myers Squibb, and Neurocrine Biosciences.

Regeneron and Sanofi announced that the FDA has postponed its decision on approving their drug, Dupixent, for treating chronic obstructive pulmonary disease (COPD). Initially, the companies sought to expand Dupixent’s use to include maintenance treatment for some adults with uncontrolled COPD. However, the FDA has requested more trial data, pushing the review deadline to September 27. This announcement coincided with a positive recommendation from EU regulators for Dupixent in treating COPD.

Andrew Bellinger, Verve Therapeutics' Chief Scientific Officer, will step down on June 21. Bellinger, who has served in this role since 2019, will transition to an advisory position. Troy Lister, the current Senior Vice President of Research and Early Development, will succeed him. Bellinger expressed on social media that it has been a privilege to serve as Verve’s first CSO and that he felt it was the right time to pursue new opportunities.

Summit Therapeutics revealed that its bispecific antibody, ivonescimab, outperformed Merck's Keytruda in a head-to-head study involving non-small cell lung cancer patients. According to Summit, ivonescimab significantly improved progression-free survival rates across different clinical subgroups compared to Keytruda. However, the company did not provide detailed data, and the trial was conducted exclusively in China. U.S. regulators often require proof that results from single-country trials are applicable to diverse demographic groups.

Bristol Myers Squibb announced that their cell therapy, Breyanzi, received FDA approval for treating mantle cell lymphoma. This follows previous approvals for large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. For mantle cell lymphoma, Breyanzi is now approved for patients who have not responded to two systemic treatments, including targeted therapies like AstraZeneca’s Calquence. The FDA’s approval was based on the TRANSCEND NHL 001 study, which showed that 85% of patients experienced a reduction in diseased white blood cells and 68% saw a complete elimination of detectable diseased cells. Breyanzi generated $364 million in sales in 2023.

Neurocrine Biosciences announced the retirement of Kevin Gorman, the company’s founder and CEO for the past 16 years. Kyle Gano, who has been with the company since 2020 as the Chief Business Development and Strategy Officer, will take over as CEO. Under Gorman’s leadership, Neurocrine made significant advancements, including the development and launch of the rare disease drug Ingrezza.

These updates highlight ongoing developments and leadership changes within key pharmaceutical and biotechnology companies, showcasing advancements in drug approvals and new therapeutic treatments.