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


Pfizer Inlyta’s Toxicity Data Help Clinch Unanimous ODAC Support

This article was originally published in The Pink Sheet Daily

Executive Summary

Axitinib as treatment for advanced renal cell carcinoma has a different toxicity profile from Bayer HealthCare's Nexavar (sorafenib), which member of the Oncologic Drugs Advisory Committee found important, even as FDA urged the panel not to focus on compartive safety and effecacy.

You may also be interested in...

Pfizer’s Inlyta Shows Greater Efficacy In Subpopulation; Will It Be Enough For ODAC And FDA?

Pfizer's Inlyta (axitinib), proposed to treat patients with advanced renal cell carcinoma, seems to work best with patients who have undergone cytokine treatment.

Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?

Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.

Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says

Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.


Related Companies




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