FDA greenlights its first therapy for advanced epithelioid sarcoma population
The FDA has revealed the approval of its first therapy for the treatment of metastatic or locally advanced epithelioid sarcoma, a rare soft-tissue sarcoma, which is not eligible for complete resection in patients of at least 16 years old: Epizyme’s Tazverik (tazemetostat).
The approval was awarded under the accelerated pathway, as well as under Orphan Drug designation.
Data derived from a trial of 62 participants receiving 800mg Tazverik twice daily and used in support of the application indicated that the overall response rate for the drug was 15% and partial response was 13%, while 1.6% of participants achieved a complete response. Of the patients that saw a response, 67% experienced a duration of response lasting at six months.
“Epithelioid sarcoma accounts for less than 1% of all soft tissue sarcomas. Until today, there were no treatment options specifically for patients with epithelioid sarcoma,” said Dr Richard Pazdur, 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. “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.”
Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has …
Eli Lilly and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) …