Penn State Hershey Medical Center home Penn State Hershey Medical Center home Penn State Hershey: Patient Care home Penn State Hershey: Education home Penn State Hershey: Research home Penn State Hershey: Community home
Penn State Hershey Health Information Library
  Library Home
  Find A Physician
  Find A Practice
  Request An Appointment
  Search Clinical Studies
  Classes and Support Groups
  Ask A Health Librarian
  Subscribe to eNewsletters

Penn State Hershey Health Information Centers
  Bone and Joint

        Follow Us

Tazverik Approved to Treat Metastatic, Locally Advanced Epithelioid Sarcoma

Approval marks the first for a drug to treat this rare soft tissue sarcoma

FRIDAY, Jan. 24, 2020 (HealthDay News) -- Tazverik (tazemetostat) has received the first approval for treatment of adults and pediatric patients 16 years and older with metastatic or locally advanced epithelioid sarcoma that cannot be resected, the U.S. Food and Drug Administration announced Friday.

The drug works by blocking activity of the EZH2 methyltransferase to help keep the cancer cells from growing. Last month, the Oncologic Drugs Advisory Committee voted unanimously that the benefits of Tazverik outweigh the risks for patients with epithelioid sarcoma, which accounts for less than 1 percent of all soft tissue sarcomas, Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, said in an agency news release.

Approval was based on clinical data from 62 patients with metastatic or locally advanced epithelioid sarcoma. Patients received 800 mg Tazverik twice a day until disease progression or unacceptable toxicity. Researchers found an overall response rate of 15 percent; 1.6 and 13 percent had a complete and partial response, respectively. Sixty-seven percent of the patients who achieved response had a response that lasted at least six months.

The most commonly reported side effects included pain, fatigue, nausea, decreased appetite, vomiting, and constipation. Patients treated with Tazverik have an increased risk for secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.

Approval was granted to Epizyme.

More Information

Health News Copyright © 2020 HealthDay. All rights reserved.