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

AstraZeneca Iressa

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's Iressa (gefitinib) is slated for review by FDA's Oncologic Drugs Advisory Committee Sept. 24. A rolling NDA for use of the epidermal growth factor receptor/tyrosine kinase inhibitor for treatment of non-small cell lung cancer was completed Aug. 5. The NDA contains two Phase II monotherapy studies in approximately 400 patients to support efficacy. Recent data from the Phase III INTACT 1 and 2 mortality trials, which examined Iressa in combination with standard platinum-based chemotherapy, failed to show a benefit in survival or symptom improvement. In announcing the results, the firm indicated that FDA could change the agenda for the Sept. 24 ODAC meeting. AstraZeneca plans to focus future studies on monotherapy use in sequential therapy regimens, with initial studies in the neoadjuvant settin
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS002008

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