Pink Sheet is part of the Business Intelligence Division 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

Synchronized Regulation: Tandem Approvals Of Xalkori, Diagnostic Required Considerable Coordination

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer’s Xalkori may be a model for fast development of a targeted oncologic and companion diagnostic, but that model is likely to be more aspiration than reality for future drug/diagnostic combinations. Extensive co-operation was required to keep two sponsors and two review centers on the same page – an effort that reflected the drug’s highly promising efficacy in early studies and FDA’s confidence that confirmatory studies would back up an accelerated approval.

Advertisement

Related Content

Regulatory Round-Up: Drug Review Profiles From 2012
Regulatory Round-Up: Drug Review Profiles From 2012
Evolution, Not Revolution, Marks Progress In Targeted Oncology Therapy – AACR
Pfizer Oncology Asia Chief Jorge Puente On Asia’s Role In Xalkori’s Success: An Interview With PharmAsia News (Part 2 of 2)
Xalkori And The Art Of Modern Drug Development
Pfizer Turns To Ventana To Expand Companion Dx Options For Xalkori
Roche and FDA in Oncology: Fighting in Public, Collaboarting in Private
Views Differ On How Lab-Developed Tests Fit In FDA Companion Dx Guidance
Pfizer’s Crizotinib Eases Past FDA With Targeted Population
Crizotinib Holds Promise For Lung Cancer, And For Pfizer Oncology

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS005037

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