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

Ipilimumab Filing For Metastatic Melanoma Planned Despite Phase III Failure

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Despite failing to meet the primary endpoint of a key study, Medarex/Bristol-Myers Squibb's investigational CTLA-4 inhibitor ipilimumab should be approved by regulators based on the totality of the data from the registration program and the limited treatment options for metastatic melanoma patients, the companies maintained

You may also be interested in...



Weak Results Stop Pfizer's Tremelimumab Phase III Trial; Bristol Keeps Going

Pfizer discontinues single-agent trial of the CTLA-4 inhibitor in advanced melanoma, but Bristol-Myers Squibb announced it is still moving forward with its CTLA-4 inhibitor ipilimumab, which also failed a monotherapy melanoma trial

Weak Results Stop Pfizer's Tremelimumab Phase III Trial; Bristol Keeps Going

Pfizer discontinues single-agent trial of the CTLA-4 inhibitor in advanced melanoma, but Bristol-Myers Squibb announced it is still moving forward with its CTLA-4 inhibitor ipilimumab, which also failed a monotherapy melanoma trial

Medarex Studying Ipilimumab As First-Line Treatment For Metastatic Melanoma

Medarex plans to initiate a clinical trial evaluating ipilimumab (MDX-010) in combination with chemotherapy as a first-line treatment for metastatic melanoma, the company said June 19

Topics

UsernamePublicRestriction

Register

MT142464

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