Beqalzi Approved for Relapsed or Refractory Mantle Cell Lymphoma

On May 13, 2026, the US Food and Drug Administration (FDA) granted accelerated approval to BeOne Medicines’ Beqalzi^™ (sonrotoclax) for the treatment of adult patients who have relapsed or refractory (R/R) mantle cell lymphoma (MCL) and have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Beqalzi is an oral, highly selective B-cell lymphoma (BCL)-2 inhibitor with a short half-life designed to promote apoptosis in malignant B‑cells. The recommended dose is 320mg taken orally once daily following completion of a four‑week dose ramp‑up, with tablets swallowed whole with food and water. The prescribing information includes warnings and precautions for tumor lysis syndrome (prophylaxis is required), serious infections, embryo‑fetal toxicity, and neutropenia. Launch is expected in the second half of this year, and cost has not yet been disclosed. Full prescribing information is available here.

At a Glance

• Brand Drug: Beqalzi^™ (sonrotoclax)
• Manufacturer: BeOne Medicines
• Date Approved: May 13, 2026
• Indication: For the treatment of adult patients with R/R MCL after at least two lines of systemic therapy, including a BTK inhibitor
• Dosage Forms Available: 1mg, 5mg, 20mg, and 80mg tablets
• Launch Date: Expected in the second half of 2026
• Estimated Annual Cost: Not yet known. 
• FDA Designation: Breakthrough Therapy. Orphan Drug. Fast Track.
• Mantle cell lymphoma (MCL) is a rare, aggressive subtype of B‑cell non‑Hodgkin lymphoma that accounts for approximately 5% of non‑Hodgkin lymphoma cases in the US, with an estimated 3,300 diagnoses annually.
• Despite initial treatment responses, most patients ultimately experience relapsed or refractory disease, with five‑year survival estimated at approximately 50%.
• Approval was supported by a single-arm, multicenter trial in patients with R/R MCL who previously received anti-CD20-based therapy and a BTK inhibitor, demonstrating an overall response rate of 52%, a median time to response of 1.9 months, and a median duration of response of 15.8 months after a median follow‑up of 11.9 months.
• Serious adverse reactions occurred in 37% of participants, most commonly pneumonia (10%).
• In the R/R MCL setting following BTK inhibitor therapy, available treatment options include cellular therapies such as Tecartus^® (brexucabtagene autoleucel – Kite/Gilead) and Breyanzi^® (lisocabtagene maraleucel – BMS); the noncovalent BTK inhibitor Jaypirca^® (pirtobrutinib – Eli Lilly); and Revlimid^® (lenalidomide – Celgene), an immunomodulatory agent indicated for patients previously treated with Velcade^® (bortezomib – Takeda) as one of the two prior therapies.
• Venclexta^® (venetoclax – AbbVie and Genentech), a BCL-2 inhibitor approved for chronic lymphocytic leukemia (CLL) is sometimes used off‑label despite the absence of an FDA approval.
• Continued approval of Beqalzi for this indication is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial, which is ongoing.
• Beqalzi is being evaluated across multiple hematologic malignancies, including Waldenström macroglobulinemia, CLL, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome, both as monotherapy and in combination regimens such as with Brukinsa^® (zanubrutinib – BeOne Medicines).