BeOne Medicines Lymphoma Drug Gets FDA Priority Review

By Adriano Marchese

BeOne Medicines said U.S. regulators have agreed to fast-track the review its new drug to treat adults with mantle cell lymphoma, a form of blood cancer.

The cancer treatment company said Wednesday that the Food and Drug Administration has accepted and granted priority review to a new drug application for sonrotoclax, a new BCL2 inhibitor intended to treat adult patients with relapsed or refractory mantle cell lymphoma.

Mantle cell lymphoma is a rare, fast-growing blood cancer that starts in the lymph nodes.

The decision was based on data from a phase 1/2 study which enrolled 125 adult patients with the specific type of blood cancer who had received prior treatment. The trial results found that sonorotoclax achieved its primary endpoints of overall response rate, and also showed promising results across several secondary efficacy endpoints, it said.

"Sonrotoclax is advancing with remarkable speed, from breakthrough therapy designation to priority review, all within a short window," Global Head of Research and Development at BeOne, Lai Wang, said.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

November 26, 2025 06:36 ET (11:36 GMT)