The US Food and Drug Administration (FDA) has approved the Epizyme, a US-based integrated biopharmaceutical firm’s supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) to treat a type of follicular lymphoma (FL).

The regulatory agency has indicated Tazverik for relapsed or refractory FL in adult patients whose tumours are positive for an EZH2 mutation and received at least two prior systemic therapies, and also for adult patients with relapsed or refractory FL left with no alternative treatment options.

Epizyme chief medical officer Shefali Agarwal said: “We are very pleased to be able to offer Tazverik as a treatment option for relapsed or refractory FL patients, which is the culmination of many years of work by our team. In our view, there remains no clear standard of care in the relapsed and/or refractory FL population as not all patients benefit from today’s available therapies.

“Based on this label, physicians will have the ability to use their clinical discretion to prescribe Tazverik 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.

“We are grateful to the many patients, physicians and medical teams who helped bring us to this important achievement.”

FDA approval is based on results from Phase 2 clinical of Tazverik

The US FDA has approved the drug under accelerated approval and granted a priority review, based on overall response rate and duration of response in Phase 2 clinical trial in FL patients with EZH2 mutations and wild-type EZH2.

Tazverik has been initially approved by the FDA on 23 January 2020 to treat adult and paediatric patients aged 16 years and older with metastatic epithelioid sarcoma not eligible for resection.

Phase 1b/3 Tazverik confirmatory trial investigator John P Leonard said: “Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma.

“The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma.”

Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Epizyme will expanding Phase 2 clinical trial cohort of FL patients to support label expansion

Epizyme is conducting a single global, randomised, adaptive confirmatory trial to evaluate the combination of Tazverik with Revlimid plus rituximab (R2), an approved chemo-free treatment regimen to treat patients with FL in the second-line or later treatment setting.

The clinical trial is planned to enrol approximately 500 FL patients, based on their EZH2 mutation status, and the safety run-in portion is underway.

The company intends to conduct post-marketing activities including expanding its Phase 2 clinical trial cohort of FL patients with wild-type EZH2, and will enrol additional patients, to support a potential label expansion in the second-line relapsed and refractory setting in the future.

Epizyme president and chief executive officer Robert Bazemore said: “This accelerated approval is an incredible achievement for Epizyme, marking the second approval for Tazverik, the first FDA approved EZH2 inhibitor, in less than six months.

“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.”