FDA approved two new treatment options for patients with difficult-to-treat blood cancers, with BeOne Medicines and Taiho Oncology each bringing novel or first-of-kind therapies to market for patients who have exhausted other options.

FDA Approves Beqalzi

The FDA has granted accelerated approval to Beqalzi (sonrotoclax), a next-generation BCL2 inhibitor, for adult patients with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy including a BTK inhibitor.¹ The approval introduces a new targeted mechanism to a patient population where treatment choices are limited and outcomes after progression are poor.

The accelerated approval is supported by data from the Phase I/II BGB-11417-201 study presented at the 2025 American Society of Hematology Annual Meeting. Among evaluable patients, sonrotoclax delivered an overall response rate of 52%, a complete response rate of 16%, a median time to response of 1.9 months, and a median duration of response of 15.8 months.¹Treatment was generally well tolerated as monotherapy.

Continued approval is contingent on confirmatory results from the ongoing Celestial-RRMCL Phase III trial. The FDA previously granted sonrotoclax Breakthrough Therapy, Fast Track, and Orphan Drug designations for this indication.

Beqalzi is also approved in China for relapsed or refractory MCL and CLL/SLL, and is under review by the European Medicines Agency. BeOne is also studying sonrotoclax in combination with zanubrutinib for CLL, with data expected at ASCO 2026.¹

"The data supporting the approval of sonrotoclax in the U.S. confirms its role as a foundational therapy for mantle cell lymphoma in the post-BTK inhibitor setting, and demonstrate that it can deliver robust disease control when treatment choices are limited and outcomes are poor," said Michael Wang, M.D., global principal investigator and professor at MD Anderson Cancer Center.

Amit Agarwal, M.D., Ph.D., chief medical officer of hematology at BeOne, said: "Today's approval of Beqalzi represents critical progress for patients with mantle cell lymphoma and reinforces our strategy of building foundational medicines designed to raise the standard of care in B-cell malignancies."

FDA Approves Inqovi

FDA has approved Inqovi (decitabine and cedazuridine) in combination with venetoclax for adults with newly diagnosed acute myeloid leukemia who are 75 years or older or ineligible for intensive induction chemotherapy, making it the first and only all-oral combination treatment approved for this population.²

The approval is supported by data from the Phase II Ascertain-V study, in which 41.6% of patients achieved complete remission with a median time to CR of two months. The median duration of complete remission was not reached at the time of analysis.²

Inqovi is a fixed-dose oral combination of decitabine and cedazuridine, where the cedazuridine component inhibits cytidine deaminase in the gut and liver to enable oral delivery of decitabine at systemic exposures comparable to intravenous administration.²

An estimated 22,720 Americans will be diagnosed with AML in 2026, with more than half likely ineligible for intensive chemotherapy due to age or health status. Prior to this approval, hypomethylating agent-based regimens for this population required frequent clinic visits for parenteral administration. An all-oral option represents a meaningful reduction in treatment burden for elderly or frail patients.

"This approval marks an important step forward in expanding how treatment can be delivered for this patient population, offering an all-oral option that can potentially reduce the overall treatment burden associated with receiving treatment in hospitals or infusion centers," said Harold Keer, MD, PhD, chief medical officer of Taiho Oncology.

Peter Melnyk, president and CEO of Taiho Oncology, said: "With the approval of an all-oral regimen, Inqovi in combination with venetoclax brings a new treatment option to this patient population and underscores our commitment to advancing innovative, patient-focused therapies in hematologic malignancies.

Sources

1. BeOne Medicines’ Beqalzi (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma BeOne Medicines May 13, 2026 https://ir.beonemedicines.com/news/beone-medicines-beqalzitm-sonrotoclax-approved-by-us-fda-as-first-and-only-bcl2-inhibitor-for/a57256f1-5e36-427a-94c3-2b6be7f2bfb9
2. U.S. FDA Approves Inqovi in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy Taiho Oncology May 13, 2026 https://www.taihooncology.com/us/news/us-fda-approves-inqovi-in-combination-with-venetoclax-the-first-all-oral-combination-treatment-for-patients-with-acute-myeloid-leukemia-who-are-ineligible-for-intensive-induction-chemotherapy/