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FDA Grants Accelerated Approval to First Therapy for Epithelioid Sarcoma
On January 23, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme) for the treatment of adults and pediatric patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma ineligible for complete resection. Tazemetostat was given Orphan Drug designation for this approval.
“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. When we brought Tazverik’s application to the Oncologic Drugs Advisory Committee last month, the committee voted unanimously that the benefits of the drug outweighed the risks,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence, in a press statement.
This approval was based on a clinical trial of 62 patients with metastatic or locally advanced epithelioid sarcoma given tazemetostat 800 mg twice daily until disease progression or unacceptable toxicity occurred. During the study, investigators conducted tumor response assessments every 8 weeks with the goal of measuring the overall response rate.
Findings yielded an overall response rate of 15%, with 1.6% of patients having complete responses and 13% having a partial response; 6 (67%) of the 9 responders had responses lasting ≥6 months.
The most frequently reported side effects with tazemetostat were pain, fatigue, nausea, decreased appetite, vomiting, and constipation. Furthermore, recipients of the drug are at increased risk for secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.—Hina Porcelli
Source: US Food and Drug Administration. FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer. January 23, 2020. www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-option-specifically-patients-epithelioid-sarcoma-rare-soft-tissue. Accessed January 24, 2020.
