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Novel cancer drug snags FDA approval.
FDA granted accelerated approval to an innovative treatment for metastatic or locally advanced epithelioid sarcoma (ES) not eligible for complete resection.
Epizyme snagged the approval for tazemetostat (Tazverik) for adults and pediatric patients 16 years and older. Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.
“Tazverik is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients.” says Robert Bazemore, president and CEO of Epizyme, in a statement.
Bazemore says he expects Tazverik to be available in early February. The drug’s WAC is reportedly around $15,000 per month.
“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.,” says Richard Pazdur, MD, 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 a statement from FDA.
Tazverik blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing. Surgical removal is considered the main treatment for ES, when it 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 time of diagnosis,” according to the FDA.
Tazverik’s approval was based on the results of a clinical trial enrolling 62 patients with metastatic or locally advanced ES. The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response.
Of the 9 patients who had a response, 67% had a response lasting 6 months or longer.
Continued approval of Tazverik is contingent upon verification and description of clinical benefit in a confirmatory trial. Epizyme said its ongoing, global, randomized, controlled confirmatory trial assessing the combination of Tazverik plus doxorubicin (Lipodox) compared with doxorubicin plus placebo as a front-line treatment for ES is underway.