Epizyme Inc. (NASDAQ:EPZM) has announced that its drug TAZVERIK (tazemetostat) has received FDA approval for supplemental New Drug Application for two distinct follicular lymphoma indications.
TAZVERIC receives approval for two follicular lymphoma patients
TAZVERIK has received sNDA for the treatment of adult refractory or relapsed FL patients that do not have a satisfactory treatment alternative. Also, it has been approved for relapsed or refractory follicular lymphoma adult patients with positive EZH2 mutation tumors. This is for tumors detected through an FDA approved test and for patients that have previously received more than two systemic therapies.
The FDA approved the indications under the accelerated priority review approval based on the ORR and DOR of patients in the second phase clinical study of follicular lymphoma patients. This was for patients showing EZH2 mutations as well as wild-type EZH2. The drug received accelerated approval on January 23 this year to treat pediatric patients above 16 years and adult patients with locally advanced epithelioid sarcoma that were ineligible for full resection.
Physicians to prescribe TAZVERIK in FL patients
Dr. Shefali Agarwal, the company’s chief medical officer, indicated that they were delighted to offer TAZVERIK for refractory or relapsed LF indications. Shefali added that currently, there is no ideal standard of care treatment for refractory and/or relapsed FL patients because not all patients benefit from the currently available therapies. Therefore based on this presumption, physicians will be able to apply their clinical decision in prescribing TAZVERIK for refractory or relapsed FL patients irrespective of the EZH2 mutation. Similarly, they can do this without regarding any particular line of therapy, especially where there are no satisfactory treatments.
Continued approval for more indications could be dependent on the description and verification of clinical benefit from confirmatory studies. The company conducts a randomized, single global adaptive confirmatory study evaluating TAZVERIK combination with Revlimid and rituximab as a chemo-free therapy for FL patients. Epizyme expects to enroll around 500 follicular lymphoma patients categorized as per their EHZ2 status. Similarly, the company will conduct post-marketing pledges.