FDA Grants Priority Review to Sonrotoclax
FDA Grants Priority Review to Sonrotoclax for R/R Mantle Cell Lymphoma
The FDA has granted priority review to a new drug application (NDA) seeking the approval of sonrotoclax (BGB-11417) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior treatment with a BTK inhibitor.
The NDA is backed by findings from the phase 1/2 BGB-11417-201 trial (NCT05471843), which achieved its primary end point of overall response rate (ORR) per independent review committee (IRC) and showed clinically meaningful responses among 125 adult patients with relapsed/refractory MCL who had been previously treated with a BTK inhibitor. Positive outcomes were also seen across several secondary efficacy end points, such as complete response rate, duration of response (DOR), and progression-free survival (PFS). Regarding safety, the trial investigators deemed sonrotoclax to be well tolerated with manageable toxicity risks.
Data supporting the NDA and priority review designation will be presented at the 2025 ASH Annual Meeting.
Previously, in October 2025, the FDA granted sonrotoclax breakthrough therapy designation as a potential therapeutic option for the treatment of patients with relapsed or refractory MCL.
“Sonrotoclax is advancing with remarkable speed, from breakthrough therapy designation to priority review, all within a short window,” Lai Wang, PhD, global head of Research & Development at BeOne Medicines, stated in a news release. “That pace reflects both the strength of the data and the urgency of the need for patients with relapsed/refractory MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL-2 inhibitor, alongside our 2 other transformative hematology assets—BTK inhibitor [zanubrutinib] and investigational BTK degrader BGB-16673.”
The FDA has granted priority review to the NDA seeking the approval of sonrotoclax for the treatment of adult patients with relapsed or refractory MCL who have received prior treatment with a BTK inhibitor.
The NDA is backed by findings from the BGB-11417-201 trial, which achieved its primary end point of ORR and demonstrated that sonrotoclax was well tolerated with manageable toxicity risks. Given the strength of these data, BeOne Medicines plans to seek global approval of sonrotoclax through channels like the FDA’s Project Orbis.
