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


Novartis Signs Xyotax Development Deal With Cell Therapeutics

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis has signed a licensing agreement with Cell Therapeutics that could potentially hasten to market the first gender-specific therapy for the treatment of non-small cell lung cancer

You may also be interested in...

CTI Xyotax PIONEER Study Closes In Favor Of Normal Estrogen Level Protocol

Cell Therapeutics will submit a new Xyotax (paclitaxel poliglumex) trial protocol to FDA by the end of the month after closing its Phase III PIONEER gender-specific lung cancer trial

Xyotax gender-specific lung cancer trial

FDA has granted Cell Therapeutics' polymer-linked paclitaxel Xyotax (paclitaxel poliglumex) fast track status for first-line treatment of poor performance status (PS2) women with advanced non-small cell lung cancer (NSCLC), the firm announces Feb. 8. The firm expects its PIONEER trial to enroll 600 women over the next 12 to 14 months; PIONEER is "the first approval trial for lung cancer exclusively targeting women," CTI states. CTI has experienced several setbacks in developing Xyotax in NSCLC, with its STELLAR trials failing to show a survival benefit in the general NSCLC population. The firm subsequently shifted its focus to women only (1Pharmaceutical Approvals Monthly September 2005, p. 16)...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 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