Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Epizyme’s Tazemetostat Gains US FDA Panel Nod For Accelerated Approval In Epithelioid Sarcoma

Executive Summary

Unanimous approval recommendation driven by data on durable responses and disease stability, although some advisory committee members suggest limiting indication to second-line use; FDA comments suggest concerns about design and feasibility of planned confirmatory trial.

You may also be interested in...



Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

The latest drug development news and highlights from our US FDA Performance Tracker.

Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Accelerated approval in epithelioid sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

Keytruda's Proposed Bladder Cancer Indication: Is Delaying Cystectomy Really A Benefit?

Oncologic Drugs Advisory Committee members wondered when Keytruda should be used since cystectomy can be curative and waiting could make the surgery more difficult.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141398

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel