Epizyme (NASDAQ:EPZM) on Thursday announced that had it secured Food and Drug Administration approval for the drug Tazverik to be used in previously treated adults with follicular lymphoma and an EZH2 mutation, and in relapsed or refractory patients with no other treatment options. Back in January, the regulator approved Tazverik as a treatment for metastatic or locally advanced epithelioid sarcoma patients who aren't eligible for surgery.
The oral medicine can reduce cancer cell growth by blocking the activity of the EZH2 enzyme. An incurable disease, follicular lymphoma develops in the white blood cells, lymphatic system, and bone marrow. It accounts for about 25% of non-Hodgkin lymphoma cases, and about 2.5 cases of it are diagnosed for every 100,000 people every year, according to the National Cancer Institute.
In clinical trials, follicular lymphoma patients with the EZH2 activating mutation who had previously received two or more therapies had an overall response rate of 69% to Tazverik, including 12% who achieved a complete response. In patients with wild-type EZH2, the overall response rate was 34%, including 4% who achieved a complete response.
Tazverik's label expansion is significant for the biotech company because far more patients are diagnosed with follicular lymphoma than epithelioid sarcoma, a soft-tissue cancer with an incidence rate of only 0.4 cases per million people. In the first quarter, Epizyme reported net sales of $1.3 million for Tazverik following its launch on Feb. 1.
In hope of earning further label expansions for Tazverik, Epizyme is also evaluating it in combination with doxorubicin as a first-line ES treatment, and is conducting a confirmatory trial of it in combination with Revlimid and Rituxan as a second-line follicular lymphoma treatment. A trial is also underway testing it in chemotherapy-naive metastatic castration-resistant prostate cancer patients alongside the blockbuster drugs Xtandi and Zytiga.