The Food and Drug Administration approved Tazverik for adults with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation and have received treatment with at least two systemic therapies, as well as patients who have no other treatment options.
The Food and Drug Administration (FDA) granted supplemental approval to Tazverik (tazemetostat) for the treatment of adults with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation and have received treatment with at least two systemic therapies.
The approval also includes adults with relapsed or refractory disease who have no other treatment options.
“In our view, there remains no clear standard of care in the relapsed and/or refractory (follicular lymphoma) population as not all patients benefit from today’s available therapies,” Dr. Shefali Agarwal, chief medical officer of Epizyme, said in a company-issued press release. “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.”
The agency gave accelerated approval to the treatment based on data from a phase 2 clinical trial that showed that patients with EZH2-mutant disease achieved an objective response rate (ORR) — the percentage of complete and partial responses to treatment – of 69% and patients with wild-type EZH2 follicular lymphoma achieved an ORR of 35%.
In the ongoing phase 2 trial, investigators evaluated Tazverik as a single agent for patients (45) with follicular lymphoma who had EZH2 activating mutations or wild-type EZH2 (54 patients) and had received at least two or more prior lines of systemic therapy.
Complete response rate for patients with an EZH2 mutation was 13%, and partial response rate for these patients was 56%. Patients with wild-type EZH2 had a 4% complete response rate and 31% partial response rate.
The duration of response — the length of time a tumor continues to respond to treatment without the cancer growing or spreading – was 10.9 months in patients from the EZH2-mutant cohort and 13 months for those with wild-type EZH2 disease.
“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,” study investigator Dr. John P. Leonard, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine, said in the press release. “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.