Data Supported Accelerated Approvals of TAZVERIK for the Treatment of Both Epithelioid Sarcoma and Relapsed/Refractory Follicular Lymphoma
Epizyme, (NASDAQ:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that The Lancet Oncology published results of the company's Phase 2 trial cohorts evaluating TAZVERIK® (tazemetostat) for the treatment of epithelioid sarcoma and relapsed/refractory follicular lymphoma. Data included in these publications supported the accelerated approval of TAZVERIK by the U.S. Food and Drug Administration (FDA) for the treatment of epithelioid sarcoma in January 2020, and the accelerated approval of TAZVERIK by the FDA for the treatment of relapsed/refractory follicular lymphoma in June 2020.
"The two publications in such a highly regarded, peer-reviewed journal as the Lancet are the culmination of years of hard work by our team, and the significant contributions by the patients and physicians who participated in our clinical trials," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "In our Phase 2 trials, TAZVERIK demonstrated durable clinical responses in both patient populations, including in patients with advanced disease who had previously received multiple therapeutic regimens. In addition, we observed consistently favorable safety with TAZVERIK, which we view as one of its most attractive features. These publications provide important support for TAZVERIK's novel epigenetic approach, and I am very proud that we are able to offer it as an approved therapy for both patient populations."
"Based on its compelling clinical data and first-in-class mechanism, we believe TAZVERIK has a pipeline in-a-product opportunity that we hope may offer benefit to patients with a wide range of cancers," said Robert Bazemore, president and chief executive officer of Epizyme. "The two FDA accelerated approvals this year highlight the therapeutic impact TAZVERIK could have for patients, and we look forward to continuing to explore its potential in additional tumor types and combinations to reach as many patients as possible."
The publications can be accessed at the following link: