Epizyme Submits New Drug Application to the US FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma.
M2 PHARMA-May 30, 2019-Epizyme Submits New Drug Application to the US FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
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- US-based biopharmaceutical company Epizyme, Inc. (NASDAQ: EPZM) has submitted a New Drug Application to the US Food and Drug Administration for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, the company said.
Tazemetostat is an oral, first-in-class, EZH2 inhibitor discovered by Epizyme and being developed for a range of cancers and treatment settings.
This NDA submission follows a recently conducted pre-NDA meeting held with FDA, in which the Agency considered the proposed clinical package to be sufficient for inclusion with the NDA.
The submission is based on updated tazemetostat efficacy and safety data from 62 patients enrolled in the epithelioid sarcoma cohort of the Phase 2 clinical trial, which will be reported in an oral presentation at the American Society of Clinical Oncology 2019 annual meeting.
The company's ongoing Phase 2 study cohort is the largest prospective clinical trial in epithelioid sarcoma with any approved or investigational anticancer treatment to date.
To support a full approval of tazemetostat for epithelioid sarcoma, Epizyme plans to conduct a global, randomized, controlled trial, that it expects to begin in the second half of 2019.
The final design of the study is subject to alignment with FDA, and the company plans to disclose details once it has reached alignment with FDA and the NDA submission has been accepted for review.
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
Epithelioid sarcoma is an ultra-rare soft tissue sarcoma characterized by a loss of the protein INI1. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age.
Median overall survival from initial diagnosis is 30 months. Epithelioid sarcoma becomes more aggressive after recurrence or metastases, with a typical survival of less than one year for patients with metastatic disease.
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, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease.
The company also is developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them.
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|Date:||May 30, 2019|
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