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FDA Grants Accelerated Approval for Epithelioid Sarcoma Treatment

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The U.S. Food and Drug administration has granted accelerated approval to tazemetostat (Tazverik) for the treatment of metastatic or locally advanced epithelioid sarcoma in adult and adolescent patients ≥16 years who are not eligible for complete resection.

In an open-label, single-arm cohort (Cohort 5) of a multi-center study (Study EZH-202, NCT02601950) in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma, the overall response rate was achieved in 15% of those treated with tazemetostat. Complete response was achieved in 1.6% of patients and partial response in 13%.

“Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies,” said Gary K. Schwartz, MD, chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase 2 trial in a press release. “The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES.”

“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,” said Robert Bazemore, president and chief executive officer of Epizyme in the press release. “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 US within 10 business days.”

Read the full press release here.

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