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news.Epizyme has secured accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat pateints epithelioid sarcoma.
The US FDA’s Centre for Drug Evaluation and Research (Credit: The U.S. Food and Drug Administration)
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Tazverik, a methyltransferase inhibitor, has been approved to treat adults and paediatric patients aged between 16 years and older with metastatic or locally advanced epithelioid sarcoma sarcoma not eligible for complete resection, based on overall response rate and duration of response in a phase 2 clinical trial.
Epizyme’s global, randomised, controlled confirmatory trial is currently evaluating the combination of Tazverik plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES.
The company will carry out certain post-marketing activities, including clinical pharmacology assessments to evaluate the effect of Tazverik on liver function, as well as the effect of CYP3A inhibitors and inducers on Tazverik to inform aspects of the prescribing information.
Epizyme will expand recruitment in cohort six of its phase 2 study, which has recruited 44 patients to date. It plans to recruit up to 60 epithelioid sarcoma patients.
Tazverik’s efficacy was assessed in an open-label, single-arm cohort 5 of a multi-center study in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma.
Epizyme said that the continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.
Epizyme president and CEO Robert Bazemore said: “Today’s accelerated approval of TAZVERIK is a landmark event for people with ES and represents our dedication to our mission of rewriting treatment for people with cancer and other serious diseases.
“TAZVERIK is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients. Our commercial launch plans are underway, and we expect to make TAZVERIK available to ES patients and treating physicians across the U.S. within 10 business days.”
In May 2019, Epizyme submitted a NDA to the FDA or accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
