The US Food and Drug Administration has granted priority review to a New Drug Application for sonrotoclax, a next-generation BCL2 inhibitor, for adult patients with relapsed or refractory mantle cell lymphoma following Bruton’s tyrosine kinase inhibitor therapy.
If approved, sonrotoclax would become the first BCL2 inhibitor for relapsed or refractory MCL in the United States, according to BeOne Medicines, the manufacturer of the therapy.
The application follows earlier Breakthrough Therapy Designation and is based on the global phase 1/2 BGB-11417-201 study in 125 heavily pretreated patients. The study met its primary endpoint of overall response rate by independent review committee and showed promising complete response rate, duration of response, and progression-free survival. The treatment was well tolerated with a manageable safety profile according to a press release by BeOne Medicines.
The company will participate in Project Orbis for concurrent international review and has submissions under review in China for relapsed or refractory MCL and relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma.
“Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review… that pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL,” Lai Wang, PhD, the global head of R&D at BeOne, said in a press release from the company.
Full results from the early phase trial will be presented for the first time at the 67th American Society of Hematology Annual Meeting and Expositio in Orlando, Florida, this week.
