Monday, June 17, 2019
Tazemetostat
tazemetostat
Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of
Patients with Epithelioid Sarcoma
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 30, 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 metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. 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 (ASCO) 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.
“Epithelioid sarcoma is a rare and aggressive cancer that affects people in the prime of their lives, and we are very pleased to have recently submitted the NDA for tazemetostat for the treatment of people with this devastating cancer,” said Dr. Shefali Agarwal, chief medical officer of Epizyme. “If approved, we believe tazemetostat has the potential to change the care of patients with this disease. We are incredibly grateful to the physicians and clinical teams who have helped advance tazemetostat to this stage, and, most notably, to the patients and caregivers who have participated in our clinical trials along the way. We look forward to continuing to engage with the FDA as we work to bring tazemetostat to patients and physicians in the U.S.”
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.
“At Epizyme, our mission is to deliver new treatments for patients with cancer and other serious diseases, and today we stand one significant step closer to achieving that,” said Robert Bazemore, president and chief executive officer of Epizyme. “This submission is the culmination of years of hard work by our entire team, and I wish to congratulate them all on this accomplishment. Our epithelioid sarcoma program is strategically valuable to Epizyme and helps streamline our planned NDA submission in the fourth quarter, for patients with follicular lymphoma. Over the coming months, we have multiple anticipated clinical data and regulatory milestones, and we are well underway with commercialization readiness activities to support the potential launch of tazemetostat and our transition to a commercial-stage organization. 2019 is set to be a transformational year for Epizyme, and I am enthusiastic for our continued progress.”
About Epithelioid Sarcoma
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.
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, 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. For
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Before having that operation, you might want to ask your surgeon's colleagues about his behavior.
ReplyDeleteA new study finds that patients whose surgeons have more complaints from coworkers about unprofessional conduct are at increased risk for complications during and after surgery.
Researchers examined data on more than 13,500 adult patients in the United States who were operated on by 202 surgeons between 2012 and 2016.
Patients whose surgeons were reported for unprofessional behavior in the 36 months before their operations were at increased risk for complications such as wound infections, pneumonia, blood clots, kidney failure, stroke and heart attack.
Unprofessional behavior included poor or unsafe practices in the operating room, disrespectful communication with coworkers, and failure to follow through on expected professional responsibilities, such as signing verbal orders.
"Surgical teams require every team member to perform at their highest level. We were interested in understanding whether surgeons' unprofessional behaviors might undermine culture, threaten teamwork, and potentially increase risk for adverse outcomes of care," said corresponding author Dr. William Cooper in a Vanderbilt University Medical Center news release. Cooper is vice president for patient and professional advocacy at the medical center.
Compared to patients whose surgeons had no reports of unprofessional behavior, those whose surgeons had one to three reports were 18% more likely to have complications, and those whose surgeons had four or more reports were nearly 32% more likely to have complications. The study only observed an association and did not prove cause and effect.
There was no difference between the two groups in rates of death, the need for a second operation, or readmission to the hospital within 30 days of their first operation, the researchers found.
In addition, female surgeons were less likely than male surgeons to get reported for unprofessional conduct, according to the study.
"Unprofessional behavior modeled by the team leads reduces the effectiveness of the team," noted study senior author Dr. Gerald Hickson, professor of medical education and administration at Vanderbilt, in Nashville, Tenn.
"It's really about common sense," he added. "If someone is disrespectful to you, how willing are you to share information or ask for advice or help from that individual?"
"Future work should assess whether improved interactions with patients, families and coworkers by surgeons who receive interventions for patterns of unprofessional behavior are also associated with improved surgical outcomes for their patients," the researchers concluded.