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This article originally appeared on OncLive®.

The FDA has granted priority review to a new drug application (NDA) seeking the approval of sonrotoclax (BGB-11417; BeOne Medicines) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior treatment with a BTK inhibitor.¹

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.²

“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.¹ “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 Brukinsa [zanubrutinib] and investigational BTK degrader BGB-16673.”

What is the design of the BGB-11417-201 trial?

This global, multicenter, single-arm, open-label trial enrolled patients at least 18 years of age with histologically confirmed MCL who had received prior systemic treatment for MCL, including an anti-CD20 agent and a BTK inhibitor.³ Patients needed to have relapsed or refractory disease and the presence of measurable disease. They were also required to have available archival tissue that confirmed their MCL diagnosis or be willing to undergo fresh tumor biopsy. An ECOG performance status of 0 to 2 and adequate organ function were also required.

In part 1 of the trial, patients (n = 22) were treated with sonrotoclax at either 160 mg or 320 mg daily to evaluate the safety and tolerability of the agent and determine the recommended phase 2 dose (RP2D) for part 2.⁴ The primary end points in part 1 included the incidence of dose-limiting toxicities, treatment-emergent adverse effects (TEAEs), serious AEs, and tumor lysis syndrome.³ Secondary end points included pharmacokinetic outcomes.

Secondary end points investigated across both parts included investigator-assessed ORR; DOR, PFS, and time to response as assessed by investigators and the IRC; and overall survival.

Part 2 enrolled 103 patients, who received sonrotoclax at the RP2D of 320 mg daily following ramp-up dosing. The primary end point in part 2 was IRC-assessed ORR. Secondary end points specific to part 2 included the incidence of TEAEs and serious AEs; the number of patients with clinically significant changes from baseline in vital signs and clinical laboratory values; the number of patients with clinically significant physical examination findings; and quality of life measures.

What other regulatory next steps are planned for sonrotoclax?

BeOne Medicines plans to participate in the FDA’s Project Orbis for sonrotoclax. Project Orbis helps facilitate the concurrent submission and review of oncology products between international regulatory bodies.¹ The company also plans to submit data from the BGB-11417-201 trial to other global regulatory agencies, including the European Medicines Agency, for the agent’s potential approval.

References

1. U.S. FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma. News release. BeOne Medicines Ltd. November 26, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/us-fda-grants-priority-review-to-sonrotoclax-for-the-treatment-of-relapsed-or-refractory-mantle/786f1dad-0c9f-492e-9fce-f9ceadd24989
2. BeOne Medicines’ sonrotoclax granted breakthrough therapy designation by U.S. FDA. News release. BeOne Medicines. October 13, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/beone-medicines-sonrotoclax-granted-breakthrough-therapy-designation-by-us-fda/7a29ff75-4388-4f81-a23e-588149f94f9e
3. Study of BGB-11417 monotherapy in participants with relapsed or refractory mantle cell lymphoma. ClinicalTrials.gov. Updated September 9, 2025. Accessed November 26, 2025. https://clinicaltrials.gov/study/NCT05471843
4. BeOne Medicines announces positive topline results for sonrotoclax in relapsed or refractory mantle cell lymphoma (MCL). News release. BeOne Medicines. August 29, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/beone-medicines-announces-positive-topline-results-for-sonrotoclax-in-relapsed-or-refractory-mantle-cell-lymphoma/9b063914-3787-4b59-95fa-1e0941571f45