FDA Approves Tazverik For Epithelioid Sarcoma

The Food and Drug Administration (FDA) granted accelerated approval to Tazverik (tazemetostat) for the treatment of adult pediatric patients, 16 years or older, with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection (the surgical removal of the tissue).

Tazverik is the first approved treatment specifically for patients with epithelioid sarcoma, a rare soft tissue cancer and sub type of soft tissue sarcoma. The FDA’s Oncologic Drugs Advisory Committee voted unanimously that the benefits of Tazverik outweighed its risks.

“Epithelioid sarcoma accounts for less than one percent of all soft tissue sarcomas,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of Tazverik provides a treatment option that specifically targets this disease.”

The fast track approval of Tazverik was granted based on the findings of a single arm cohort in a phase 2 clinical trial of Tazverik. Of the 62 patients treated with Tazverik the overall response rate was 15%, with 1.6% of those patients achieving a complete response, and 13% achieving a partial response. 67% of the patients treated had a duration of response for six months or longer.

“Tazverik is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients,” stated Robert Bazemore, president and chief executive officer of Epizyme (the biopharmecutical company behind the drug, in a press release. “Our commercial launch plans are underway, and we expect to make tazverik available to patients (with epithelioid sarcoma) and treating physicians across the U.S. within 10 business days.”

According to the company’s press release, 37% of the patients experienced serious side effects to Tazverik including hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. However, the most common side effects of the treatment, experienced by greater than 20% of the patients treated, were pain, fatigue, nausea, decreased appetite, vomiting and constipation.

The current recommended dosage of tazverik is 800mg taken orally twice a day.

Check back later on what you need to know about this approval.