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


Will Weak Standard Of Care Lower Approval Bar For PegIntron For Melanoma?

Executive Summary

FDA may be more likely to approve Schering-Plough's PegIntron for melanoma based on a modest improvement in relapse-free survival, without an effect on overall survival, with support from its Oncologic Drugs Advisory Committee that the survival advantage for the standard of care - Schering's own Intron A - is questionable

You may also be interested in...

Despite FDA Reservations, ODAC Votes Yes On Schering's PegIntron And GSK's Votrient

The panel voted 6-4 to recommend approval of the sBLA for PegIntron (peginterferon alfa-2b) for melanoma, and unanimously for Glaxo's Votrient (pazopanib) for advanced renal cell carcinoma.

Melanoma Trials Should Allow Intron A-Naïve Patients, Advisory Cmte. Says

Enrollment in melanoma drug trials should not be restricted to patients who have failed interferon alfa therapy, FDA's Oncologic Drugs Advisory Committee concluded Feb. 27

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011





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