Epizyme gets FDA approval for TAZVERIK™ to treat epithelioid sarcoma
Category: #health  By Pankaj Singh  Date: 2020-01-25
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Epizyme gets FDA approval for TAZVERIK™ to treat epithelioid sarcoma

Epizyme, Inc., a renowned biopharmaceutical company developing new epigenetic therapies, has reportedly announced that the United States Food and Drug Administration has granted the accelerated approval of the company’s drug candidate, TAZVERIK™, for the treatment of adults as well as pediatric patients aged 16 years and above suffering from metastatic or advanced epithelioid sarcoma (ES) and are not suitable for complete surgical resection, that is built on overall response rate and duration of response in a Phase 2 clinical trial.

Gary K. Schwartz, M.D., and an investigator for Phase 2 trial of Epizyme’s TAZVERIK, stated that in spite of the advancements in the industry, there have been limited therapeutic options available for the treatment of patients suffering from epithelioid sarcoma and struggling with high rates of relapse and toxicities related to presently used therapies.

Schwartz further stated that the TAZVERIK data from the ES cohort in the Phase 2 trial of Epizyme support its ability to provide clinically meaningful and durable responses, and acceptability for ES patients. This approval of TAZVERIK signifies an important development in the treatment of patients with ES.

Robert Bazemore, President and CEO, Epizyme, stated that the TAZVERIK accelerated approval is a significant event for patients with ES and showcases the dedication of the company towards its treatment rewriting mission for people diagnosed with cancer and other severe diseases.

Bazemore, further stated that TAZVERIK would be the first FDA approved EZH2 inhibitor, as well as the first and only FDA approved treatment exclusively specified for ES patients. The company’s commercial launch plans are in progress and the company is expecting to make TAZVERIK available to ES patients and for treating patients throughout the U.S. in 10 business days.

Denise Reinke, president and CEO, SARC, stated that for people suffering from epithelioid sarcoma, a life-threatening cancer affecting young adults, having new options for treatment could offer a lot of hope.

Dr. Shefali Agarwal, CMO, Epizyme, stated that discovering, advancing and gaining the approval from FDA for TAZVERIK, with its new mechanism of action, has been the result of many years of work and commitment by a number of people, which also includes the patients, physicians and caregivers that took part in the company’s clinical trials, and the talented Epizyme team.

Epizyme would also conduct some post-marketing activities, that includes clinical pharmacology evaluations to review the impact of TAZVERIK on liver function as well as effect of CYP3A inducers and inhibitors on TAZVERIK to notify aspects of the prescribing information.
 

Source credit: https://epizyme.gcs-web.com/news-releases/news-release-details/epizyme-announces-us-fda-accelerated-approval-tazveriktm

 



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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