Select Language:
BeOne Medicines announced that its innovative drug for relapsed or refractory mantle cell lymphoma has received accelerated approval from the U.S. Food and Drug Administration. The medication, sonrotoclax, was approved for treating patients with relapsed or refractory MCL who have undergone at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor. This marks the first new BCL2 inhibitor approved in the United States in a decade and the only one approved specifically for MCL.
Designed as a core BCL2 inhibitor, sonrotoclax offers increased potency and selectivity, with the potential to enhance effectiveness, improve tolerability, and provide greater convenience compared to other drugs in its class. Mantle cell lymphoma, a rare and often aggressive form of non-Hodgkin lymphoma, affects approximately 3,300 new patients annually in the U.S., according to company data. While many initially respond to treatment, relapse is common and outcomes after progression, especially following prior BTK inhibitor therapy, tend to be poor.
The FDA’s accelerated approval for sonrotoclax introduces a targeted mechanism to the current MCL treatment options and emphasizes the need to broaden therapeutic choices as the disease progresses.
Amit Agarwal, Chief Medical Officer of hematology at the company, stated, “We are leading the evolution of BCL2 inhibition to change how we treat patients with B-cell cancers. The approval of sonrotoclax is a significant step forward for MCL patients and aligns with our mission to develop foundational medicines that set higher standards in B-cell malignancy care.”
The FDA granted the drug Breakthrough Therapy Designation for this indication, along with Fast Track and Orphan Drug designations. Accelerated approval allows the drug to be marketed based on early evidence and surrogate endpoints for serious or life-threatening diseases with unmet medical needs, although additional clinical data will need to be submitted to confirm its efficacy.
In January, Chinese regulators approved sonrotoclax for two indications, including the one approved by the FDA.
Shares of the company closed 4.3% lower at CNY249.70 (approximately USD36.79) on the Shanghai Stock Exchange today after an earlier rise of more than 1.6%. The decline followed a broad market selloff as investors took profits amid recent gains over the past six weeks. The Shanghai Composite Index fell 1.5%, while the Hong Kong-listed stock dropped 1.7% to HKD184.70 (roughly USD23.58), with the Hang Seng Index remaining unchanged.
ChatGPT
Perplexity
Gemini AI
Grok AI
