News
The U.S. Food and Drug Administration (FDA) Approves Sonrotoclax for Mantle Cell Lymphoma
May 13, 2026 – On May 13, 2026, the U.S. Food and Drug Administration (FDA) announced it has approved sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
BCL-2 inhibitors are a type of targeted therapy. Targeted therapies are a type of cancer treatment that targets proteins that control how cancer cells grow, divide, and spread.
Learn About Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is a rare B-cell non-Hodgkin lymphoma (NHL). It often starts out as a slow-growing disease, but can become faster-growing over time.
“The FDA’s accelerated approval of sonrotoclax for relapsed or refractory mantle cell lymphoma represents meaningful progress for patients facing this aggressive disease, particularly those whose lymphoma has returned after multiple prior therapies,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. Expanding treatment options is critical for the lymphoma community, and this approval offers new hope to patients and families in need of additional effective therapies.”
For more information on the FDA approval of sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), visit the FDA’s website.
Update on Mantle Cell Lymphoma Webinar
Led by a lymphoma expert, this virtual interactive program will provide an overview of mantle cell lymphoma (MCL), including the latest treatment approaches, emerging research, and the role of clinical trials. Attendees will also have the opportunity to ask questions during a live Q&A session.