Submission Marks On-time Execution of Second NDA Submission for Tazemetostat in 2019
Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy. Tazemetostat is an oral, first-in-class EZH2 inhibitor being developed for a range of cancers and treatment settings.
"We are very pleased to have submitted this NDA in hopes of bringing tazemetostat to FL patients and their physicians," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "FL remains a devastating and incurable disease. We believe that if approved, the durable responses and favorable safety observed in patients both with and without an EZH2 activating mutation support tazemetostat’s potential to make a meaningful difference for these patients. This FL NDA submission, on the heels of a positive Oncology Drug Advisory Committee meeting for our epithelioid sarcoma program just yesterday, sets us up for a transformational year in 2020. We are grateful to the patients and medical teams who have meaningfully contributed to advancing tazemetostat to this stage."
Epizyme’s FL NDA submission follows a pre-NDA meeting held with FDA in October 2019, in which the Agency indicated that it considered the proposed clinical package to be sufficient for inclusion as part of the NDA for accelerated approval. The submission is based primarily on updated Phase 2 efficacy and safety data on tazemetostat in this patient population, which were presented at the 2019 American Society of Hematology (ASH) Annual Meeting. The data demonstrated that treatment with tazemetostat resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).
To support a full approval of tazemetostat for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of tazemetostat with "R2" (Revlimid® plus Rituxan®), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. Site initiation is underway, and the safety run-in portion of the trial has begun.
"Today’s submission marks the second NDA for tazemetostat that Epizyme executed this year, a significant milestone for our company, and a strong conclusion to 2019 across all aspects of our business," said Robert Bazemore, president and chief executive officer of Epizyme. "I am incredibly proud of what this team has achieved this year, which includes two NDA submissions, a favorable ODAC meeting for our epithelioid sarcoma program, important clinical data readouts, expansion of our tazemetostat clinical program into new indications and combinations, and a significant strengthening of our balance sheet with capital to support our planned operations into 2022. We are on the cusp of a potential first approval of tazemetostat, and are ready to make the transition to a commercial-stage organization in early 2020."
The FDA has a 60-day review period to determine whether the FL NDA submission is complete and acceptable for filing.
About Epizyme, Inc.
Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, an oral, first-in-class EZH2 inhibitor, with investigational studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also exploring additional molecules in its novel G9a inhibitor program. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. For more information, visit www.epizyme.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether the FDA will approve the NDA submitted for tazemetostat; whether results from clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; whether Fast Track Designation and Orphan Drug Designations will provide the benefits for which tazemetostat is eligible; expectations for regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the company's cash resources will be sufficient to fund the company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the company's therapeutic candidates; and other factors discussed in the "Risk Factors" section of the company's most recent Form 10-Q filed with the SEC and in the company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date hereof and should not be relied upon as representing the company's views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
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Erin Graves, Epizyme, Inc.
Alicia Davis, THRUST Strategic Communications