Approval Would Expand TAZVERIK™ Label into Second Indication
PDUFA Target Action Date Scheduled for June 18, 2020
Epizyme, Inc. (Nasdaq: EPZM), a fully integrated commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for the accelerated approval of TAZVERIK™ (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. The FDA granted Priority Review and has designated the company’s application as a supplemental NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020. Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
"Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "If approved, we believe TAZVERIK could become an important new option for these patients and their physicians. We are thrilled with FDA’s acceptance of our application as an sNDA with Priority Review, for TAZVERIK for patients with relapsed or refractory FL. We look forward to working with the Agency during their review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable in bringing us to this point."
"On the heels of our first approval for TAZVERIK for epithelioid sarcoma last month and a successful launch into the market, this sNDA filing acceptance brings us one step closer to providing TAZVERIK to a larger patient population," said Robert Bazemore, chief executive officer of Epizyme. "The June 2020 PDUFA date positions TAZVERIK for two FDA approvals within six months of each other, which would be a remarkable achievement for Epizyme. We are actively building off our experience with our ES commercial launch, in order to seamlessly expand to an FL launch where we anticipate rapid market adoption, if approved."
Epizyme’s sNDA submission is based primarily on updated Phase 2 efficacy and safety data for TAZVERIK in this patient population, which were presented at the 2019 American Society of Hematology (ASH) Annual Meeting. The data demonstrated that treatment with TAZVERIK 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 TAZVERIK for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of TAZVERIK 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. The safety run-in portion of the trial is underway, and the company expects to advance into the efficacy portion of the Phase 1b/3 trial in 2020.
TAZVERIK™ (tazemetostat) is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For the full prescribing information, please visit www.TAZVERIK.com.
About Epizyme, Inc.
Epizyme, Inc. is a fully integrated commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK™ (tazemetostat), for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match 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 tazemetostat will receive marketing approval for epithelioid sarcoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory trial; 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; 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 success of tazemetostat or 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.
TAZVERIK™ is a trademark of Epizyme, Inc.
Erin Graves, Epizyme, Inc.
Alicia Davis, THRUST Strategic Communications