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

Questions Surround Merck’s Withdrawal Of Keytruda Filing For Lung Cancer In EU

Executive Summary

The withdrawal of Merck’s Keytruda NSCLC application in Europe suggests the firm filed too early, and it will now need to wait for the results of the Phase III KEYNOTE-189 study before submitting the drug again to the EMA.

You may also be interested in...



Roche Causes Stir With Tecentriq/Avastin/Chemo Lung Cancer Win

There are no actual data yet but the news that the closely-watched IMpower 150 study met a goal of progression-free survival and showed 'encouraging' signs on the overall survival endpoint has made IO rivals sit up, especially Merck & Co.

CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin

At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.

Merck Stresses Overall Survival In Keytruda/Chemo '189 Trial Revamp

Merck is changing the statistical analysis of combination study in first-line lung cancer to include dual endpoints of progression-free-survival and overall survival, and has withdrawn a filing for the combination in Europe based on mid-stage data.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121865

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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