Tazemetostat receives FDA approval for the treatment of epithelioid sarcoma

The U.S. Food and Drug Administration approved tazemetostat for treating adults and pediatric patients of age 16 and older suffering from metastatic or locally advanced epithelioid sarcoma not appropriate for complete resection.

Tazemetostat inhibits the activity of the EZH2 methyltransferase that might assist the growth of cancer cells. The majority cases of epithelioid sarcoma start in the soft tissue beneath the skin of an extremity, although it can begin in other parts of the body. Removal with surgery is the thought to be primary therapy when the cancer is restricted to one area of the body. Radiation or chemotherapy may also be provided.

Though, there is an elevated possibility for the local and regional spread of the disorder even after therapy. About 50% of patients have metastatic disorder at the diagnosis time.

The tazemetostat was approved depending on the outcomes of a clinical trial, including sixty-two patients with epithelioid sarcoma. In the clinical trial, patients were given 800 mg of tazemetostat two times daily until the condition improved, or the patient attained an intolerable toxicity level.
Tumour response evaluations were done every eight weeks for the period of the clinical trial. The overall response rate (ORR) was calculated in the trials. 15% was the ORR, and 1.6% of patients had a complete response, and 13% of the patients had a partial response. Six patients among the nine patients, who had a response, had a response durable for six months or more.

Accelerated Approval was granted to tazemetostat that allows the FDA to approve drugs for severe ailments to complete an unmet medical requirement based on the outcome, which is rationally expected to provide a clinical benefit to patients. Tazemetostat has also given Orphan Drug designation that offers incentives to help and promote the drugs development for rare disorders.