Tazverik gets U.S. FDA nod for the treatment of epithelioid sarcoma

·         Tazverik received accelerated approval, that allows FDA to permit medication for serious ailments

·         The drug was also granted Orphan Drug designation that offers incentives encouraging production 

The U.S. Food and Drug Administration has reportedly approved the use of Tazverik (Tazemetostat) – an experimental cancer drug towards the treatment of metastatic or epithelioid sarcoma in adults and pediatrics aged 16 or more.

According to Richard Pazdur, M.D, and Director of the Oncology Centre of Excellence, FDA and the Acting Director of the Office of Oncological Diseases in the Center for Drug Evaluation and Research at FDA, Epithelioid sarcoma is responsible for less than 1% of the total cases of all soft tissue sarcomas. Tazverik is a novel drug discovery that specifically targets the illness, he further added.

For the record, the drug restricts the working of the EZH2 methyltransferase, which primarily assists in preventing the cancer cells from growing. Most incidences of epithelioid sarcomas first affect the soft tissue lying underneath the skin of extremity; however, it can start in any other area of the body.

Once the cancer is detected, first-hand treatment suggests surgical removal while other solutions such as radiation and chemotherapy may also be given. In most cases, there is a high chance of local spread of the disease despite the treatment and close to 50% of the patients suffer from metastatic disease during the diagnosis.

Apparently, the FDA approval is centered around the results of a clinical trial comprising of 62 patients affected with metastatic or locally developed epithelioid sarcoma. The volunteers were given 800 milligrams of Tazverik two times per day during the clinical study until the condition improved or the patients reached the maximum tolerance level of toxicity.

During the trial, the response analysis was monitored every eight weeks and examined as to how many patients experienced partial or complete shrinkage of the tumor. The total response rate was measured at 15%, with close to 13% of the patients showcasing partial response and 1.6% having complete response. Out of the nine patients that showcased response, 6% had a response that lasted for six months or more.

 

Source Credits: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-option-specifically-patients-epithelioid-sarcoma-rare-soft-tissue