Tazverik has received the first approval for treatment of adults and pediatric patients 16 years and older with metastatic or locally advanced epithelioid sarcoma that cannot be resected, the U.S. Food and Drug Administration announced.
The tazemetostat drug works by blocking activity of the EZH2 methyltransferase to help keep the cancer cells from growing. Last month, the Oncologic Drugs Advisory Committee voted unanimously that the benefits of Tazverik outweigh the risks for patients with epithelioid sarcoma, which accounts for less than 1 percent of all soft tissue sarcomas, Dr. Richard Pazdur, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, said in an agency news release Friday.
Approval was based on clinical data from 62 patients with metastatic or locally advanced epithelioid sarcoma. Patients received 800 mg Tazverik twice a day until disease progression or unacceptable toxicity. Researchers found an overall response rate of 15 percent; 1.6 and 13 percent had a complete and partial response, respectively. Sixty-seven percent of the patients who achieved response had a response that lasted at least six months.
The most commonly reported side effects included pain, fatigue, nausea, decreased appetite, vomiting, and constipation. Patients treated with Tazverik have an increased risk for secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome and acute myeloid leukemia.
Approval was granted to Epizyme.
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