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

Bristol Melanoma Drug's Advisory Panel Delayed Following Review Date Delay

This article was originally published in The Pink Sheet Daily

Executive Summary

Additional Phase III data for ipilimumab might be available by next year, and an early March advisory committee date now looks likely, given the rescheduled PDUFA date of March 26, 2011.

You may also be interested in...



Advisory Panel To Consider Vandetanib's New Life In Niche Thyroid Cancer

After missing the boat in non-small cell lung cancer, AstraZeneca has repositioned the drug for the rare advanced medullary thyroid cancer.

Advisory Committee Review Will Test Whether One Trial Will Do The Trick For Bristol's Ipilimumab

Panelists may want to wait for results from a second Phase III trial and, given severe side effects, are likely to want a robust risk management plan.

BMS Files Ipilimumab With FDA And EMA, Positioning It For Launch Next Year

If approved, the CTLA-4 inhibitor would be the first new drug for the treatment of metastatic melanoma in over a decade.

Topics

UsernamePublicRestriction

Register

GB140150

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