Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
Epizyme’s tazemetostat, an oral potent, first-in-class EZH2 inhibitor, won accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
The company said the approval of the drug, now dubbed Tazverik, was based on the overall response rate and duration of response in a Phase II clinical trial. In December, the FDA’s Oncologic Drugs Advisory Committee unanimously supported the approval of Tazverik for Epithelioid sarcoma.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma (ES), a soft-tissue cancer.
“Tazverik is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients. Our commercial launch plans are underway, and we expect to make Tazverik available to ES patients and treating physicians across the U.S. within 10 business days,” Bazemore said.
According to the Mayo Clinic, epithelioid sarcoma typically begins as a painless firm growth or lump on the skin. Sometimes the lumps can appear as ulcers, looking like open wounds over the growths, the Mayo Clinic said. The sarcoma is marked by a loss of the INI1 protein. Patients typically do not live five years beyond the diagnosis.
The Phase II studies that supported the approval of the overall response rate was 15%, with 1.6% of patients achieving a complete response and 13% achieving a partial response. Among responders in the trial, 67% had a duration of response of six months or longer, the company said. Serious adverse reactions occurred in 37% of patients. The most common adverse reactions were pain, fatigue, nausea, decreased appetite, vomiting and constipation.
Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Additionally, Epizyme said it will conduct certain post-marketing activities, including clinical pharmacology evaluations to assess the effect of Tazverik on liver function and the effect of CYP3A inhibitors and inducers on Tazverik to inform aspects of the prescribing information.
“Discovering, developing and obtaining FDA approval for Tazverik, with its novel mechanism of action, is the result of years of work and commitment by many people, including the patients, caregivers and physicians who have participated in our clinical trials, along with the talented team at Epizyme. We are tremendously proud of this important milestone and look forward to further advancing clinical development of tazemetostat for multiple types of cancers,” Shefali Agarwal, the company’s chief medical officer.
Last month Epizyme submitted a New Drug Application NDA for tazemetostat for relapsed or refractory follicular lymphoma, with or without EZH2 activating mutations, in patients who have received at least two prior lines of systemic therapy.
