The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
Shares of Epizyme stock jumped about 5% Thursday afternoon after its first-in-class EZH2 inhibitor Tazverik won approval from the U.S. Food and Drug Administration (FDA) for the second time this year.
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications. Tazverik was approved to treat adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. The FDA also approved Tazverik as a treatment for adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options. The FDA approved both of these indications under accelerated approval with a priority review, based on overall response rate and duration of response in the company’s Phase II clinical trial cohorts of FL patients with EZH2 mutations and wild-type EZH2.
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Epizyme is conducting a confirmatory trial of 500 FL patients to evaluate the combination of Tazverik with “R2” (Celgene’s Revlimid plus the chemotherapy drug rituximab) for FL patients in the second-line or later treatment setting. In addition, Epizyme plans to conduct post-marketing commitments, including an expansion of its Phase II clinical trial cohort of FL patients with wild-type EZH2 who have been treated with at least one prior systemic treatment to enroll additional patients, in order to support a potential label expansion in the second-line relapsed and refractory setting in the future.
In the Phase II study that secured approval, patients treated with at least two prior systemic therapies saw a 69% overall response rate, with 12% of patients achieving a complete response and 57% achieving a partial response. The median DOR was 10.9 months and ongoing, Epizyme said. Among the FL patients with wild-type EZH2 who received Tazverik, the ORR was 34%, with 4% of patients achieving a complete response and 30% achieving a partial response. The median DOR was 13 months.
In January, the FDA first approved Tazverik 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. That approval marked the first time the FDA had approved an EZH2 inhibitor.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tazverik an incredible treatment for the company and the first-ever approved EZH2 inhibitor.
“Building off our successful commercial launch of Tazverik for epithelioid sarcoma earlier this year, we have seamlessly expanded our organization and are fully prepared to begin engaging physicians and to launch in FL. The ability to reach patients who need a new treatment like Tazverik is at the core of everything we do, and we are incredibly proud of this milestone and the ability to impact patients’ lives,” Bazemore said in a statement.
Shefali Agarwal, chief medical officer of Epizyme said with the latest approval of Tazverik, physicians will have the ability to use their clinical discretion to prescribe the medication for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory.
