Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Panitumumab first-line CRC trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Amgen/Abgenix initiate a Phase III trial of the epidermal growth factor receptor antagonist panitumumab in first-line metastatic colorectal cancer, the firms announce April 26. The open-label PACCE (Panitumumab Advanced Colorectal Cancer Evaluation) trial will randomize 1,000 patients to receive panitumumab on top of either an oxaliplatin- (Sanofi-Aventis' Eloxatin) or irinotecan-based (Pfizer's Camptosar) regimen. Amgen is also preparing to submit an application in the second half of 2005 for panitumumab's use in third-line CRC (1Pharmaceutical Approvals Monthly April 2005, In Brief)...

You may also be interested in...



Amgen preps panitumumab NDA

Amgen plans to submit its epidermal growth factor receptor inhibitor panitumumab in the second half of 2005 for treatment of third-line colorectal cancer, the firm says March 29. Two Phase III trials, one each in the U.S. and EU, are ongoing. "In recent discussions with the FDA, we have obtained favorable opinion regarding the acceptability of these studies for U.S. registration," Senior Director-Licensing Anthony Gringeri, PhD, tells investors at the Smith Barney Citigroup Healthcare conference. Amgen maintains the monoclonal antibody has advantages over Bristol-Myers Squibb/ImClone's EGFR agent Erbitux (cetuximab), including "fewer infusion reactions"...

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows

A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS002903

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