The Food and Drug Administration granted a priority review to a new drug application for the accelerated approval of tazemetostat to treat metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
BY Kristie L. Kahl
The Food and Drug Administration (FDA) granted a priority review to a new drug application for the accelerated approval of tazemetostat to treat metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, according to Epizyme, the drug’s manufacturer.
“We are thrilled with FDA’s acceptance of this first tazemetostat (new drug application) submission for priority review, and to be an important step closer to achieving our mission of rewriting treatment for patients with cancer and other serious diseases,” Robert Bazemore, president and chief executive officer of Epizyme, said in a release, adding that this is a significant achievement in the drug’s development.
The priority review
– which is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition – was based on results from the sarcoma cohort of an ongoing phase 2 study that was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The study showed that tazemetostat resulted in clinically meaningful and durable responses, and was generally well-tolerated.
To support full approval for the agent in the future, Epizyme plans to initiate a global confirmatory trial in the front-line treatment setting comparing tazemetostat in combination with doxorubicin versus placebo plus doxorubicin in approximately 150 patients.
“If approved, we believe tazemetostat could become an important new option in the treating physicians’ arsenal,” Bazemore said. “We would like to extend our sincerest gratitude to those patients, families and medical teams who have participated in our clinical studies and helped bring tazemetostat to this stage.”
The FDA is set to make its decision by Jan. 23, 2020.