Biopharmaceutical company Epizyme Inc. (NASDAQ: EPZM) on Thursday said that its tazemetostat drug for the treatment of patients with epithelioid sarcoma had been approved by the Food and Drug Administration.
The TAZVERIK drug has been approved, particularly for the treatment of patients above the age of 16, who have metastatic or locally advanced epithelioid sarcoma that cannot be completely removed with surgery.
The clinical benefit of the drug still needs to be verified in a confirmatory trial for the FDA's continued approval, as is usually required in cases where the federal agency grants accelerated approvals based on preliminary trials.
Epizyme said that it is already performing a confirmatory trial that assesses the effects of a combination of TAXVERIK and chemotherapy drug Doxorubicin against a combination of the latter with a placebo.
The company reported a 15% response rate at a 95% confidence interval among the 62 patients treated in the phase 2 trials, and a 1.6% complete response.
77% of these patients had had prior surgeries, and 61% prior systemic chemotherapy, Epizyme said.
37% of patients reported adverse reactions from the drug, and 2% permanently discontinued it due to the side effects.
"TAZVERIK is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients," Epizyme CEO Robert Bazemore, said in a statement.
"Our commercial launch plans are underway, and we expect to make TAZVERIK available to ES patients and treating physicians across the U.S. within 10 business days."
Epizyme's shares traded 1.76% lower in the after-hours market after closing the regular session 4.74% higher at $26.72.
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