BeiGene’s BRUKINSA wins accelerated approval from the FDA for MCL
Category: #health  By Vikas M  Date: 2019-11-16
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BeiGene’s BRUKINSA wins accelerated approval from the FDA for MCL
  • BRUKINSA is the first product from BeiGene to get approval from the FDA
     
  • 84% of patients who are talking BRUKINSA have achieved an ORR

BeiGene, Ltd., a biopharmaceutical firm focused on the development and commercialization of innovative immuno-oncology drugs to treat cancer, recently announced the United States Food and Drug Administration (FDA) has given an accelerated approval to BRUKINSA (zanubrutinib) for the treatment of mantle cell lymphoma (MCL) found in adult patients who have received minimum of one therapy before.

BRUKINSA is reportedly the first product discovered by BeiGene that has been approved. This has become an important milestone for the company’s aim to transform treatment for all cancer patients worldwide. The accelerated approval given by the FDA is based on the overall response rate (ORR).

BeiGene’s CEO, Co-Founder and Chairman, John V. Oyler stated that the company has been making efforts to improve the outcomes for people suffering from cancer across the world and the approval will help the company step a little closer to their goal of providing the best quality therapies to patients.

Oyler further added that the approval by FDA for BRUKINSA right after the Breakthrough Therapy designation was given for the indication, further validates it as the prime option for treatment for people who are suffering from refractory or relapsed MCL.

Meghan Gutierrez, CEO of Lymphoma Research Foundation commented that the approval of BRUKINSA as a second-line therapy represents a major advancement in the treatment of mantle cell lymphoma. Varied and expanded options for treatment are capable of transforming the experience and providing a chance for patients living with mantle cell diagnosis.

Jane Huang, M.D., BeiGene’s Chief Medical Officer of Hematology stated that BRUKINSA happens to be a BTK inhibitor which was originally designed to amplify the target occupancy and lessen the off-target binding. The company’s broad development program has enrolled over 1,600 patients globally since the inhibitor entered the clinic in 2014.  

 

Source Credit- https://finance.yahoo.com/news/u-fda-grants-beigene-brukinsa-212048146.html

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Vikas M    

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