publication date: Jan. 24, 2020
Drugs & Targets
FDA grants Tazverik accelerated approval as first treatment option for epithelioid sarcoma
FDA granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients ages 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.
The FDA Oncologic Drugs Advisory Committee voted to recommend approval for the drug at its December meeting (The Cancer Letter, Dec. 20, 2019).
“Epithelioid sarcoma accounts for less than one percent of all soft tissue sarcomas,” 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, said in a statement. “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.”
Tazverik blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing. Most cases of epithelioid sarcoma begin in the soft tissue under the skin of an extremity, though it can start in other areas of the body. Surgical removal is considered the main treatment when the cancer is localized to one area of the body. Chemotherapy or radiation may also be given. However, there is a high likelihood for local and regional spread of the disease even with treatment and approximately 50% of patients have metastatic disease at the … Continue reading FDA grants Tazverik accelerated approval as first treatment option for epithelioid sarcoma
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