According to a press release from Epizyme, Priority Review has been granted for tazemetostat (Tazverik), a drug used to treat relapsed or refractory follicular lymphoma (FL) for patients whose symptoms persist after two prior treatments. The promising new drug now enters a phase in which it will be considered for accelerated approval and as a supplemental New Drug Application (NDA).

Follicular Lymphoma

Follicular lymphoma is a rare cancer that effects the lymphatic system, a part of the immune system that carries white blood cells. The disease is slow growing, with symptoms including swollen lymph nodes, sleepiness, shortness of breath, fever, sweats, and weight loss. There is symptomatic treatment, but no cure. The condition is considered relapsed if it has returned after a period of remission, and it is considered refractory when the disease is unresponsive to any treatment options or the positive effects of care don’t stick.

Priority Review

The phase 2 trial showed the drug to be effective for patients with both the EZH2 activating mutation and EZH2 wild type, with an objective response rate at 69% and 35% respectively. The drug now moves on to a global adaptive trial that will be used to test the drug in tangent with an already approved chemo-free treatment scheme. The drug manufacturer Epizyme hopes for the drug to become a reliable new option for the many patients who to date have no effective options. This step already brings them closer to providing access to a more general patient pool. The phase 1b/3 trial will begin in 2020 and will include 500 FL patients divided by their specific mutation’s subtype.

The status of Priority Review is designated for therapies that could be groundbreaking in treating serious illnesses and conditions.  The CEO of Epizyme, the biopharmaceutical company which manufacturers the drug, is hoping for the drug to pass accelerated approval by this summer.

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