Beigene Ltd. (NASDAQ: BGNE) stock surged by 2.64% at last close while the BGNE stock price soars by 14.22% in the pre-market trading session. BeiGene is a scientific biotechnology firm with a global focus on creating novel and affordable medications to improve treatment efficacy and access for patients throughout the world.
BGNE stock Significant Development
The US Food and Drug Administration has granted fast clearance to BRUKINSA (zanubrutinib) for the cure of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have had at least one anti-CD20-based therapy.
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The overall response rate is the basis for this speedy approval. Ongoing approval for this purpose could be conditional on a confirmatory trial demonstrating and documenting clinical benefit. BRUKINSA was approved by the FDA primarily on efficacy data from two single-arm clinical trials, with ORR as the primary endpoint, as determined by an independent review committee using the 2014 Lugano Classification.
BRUKINSA should be administered orally with or without food at a dose of 160 mg twice daily or 320 mg once daily. For people with serious hepatic impairment and certain drug interactions, the dose may be lowered or changed in response to adverse responses.
Jane Huang, Chief Medical Officer, Haematology at BeiGene commented,
The FDA’s approval of BRUKINSA in patients with a history of marginal zone lymphoma is a major accomplishment that was achieved by the hard work of the BeiGene team, the devoted investigators, and the patients and families who took part. The MAGNOLIA trial results added to the evidence that BRUKINSA’s selective design can lead to better treatment outcomes for these individuals.
The continued examination of BRUKINSA in a large worldwide clinical trial will help us learn more about this possibly best-in-class BTK inhibitor and its effects on patients. BRUKINSA has received 12 approvals in four indications since its initial FDA approval in November 2019. They will continue to carry out the aim of improving cancer patients’ access to new and high-quality treatments around the world.