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



Executive Summary

NCI's CHABNER QUESTIONS TAXOL ADMINISTRATION LABELING CHANGE recommended by FDA's Oncology Drugs Advisory Committee at its Sept. 23 meeting. The committee agreed that paclitaxel should be infused over three hours rather than the currently recommended 24 hours ("The Pink Sheet" Sept. 27, T&G-8). National Cancer Institute Division of Cancer Treatment (DCT) Director Bruce Chabner commented on the proposed change at the Oct. 18-19 meeting of DCT's Board of Scientific Counselors. "I have reservations about the decision to relabel Taxol," Chabner asserted. "I realize the logistic advantages of three-hour infusions; however, preclinical studies clearly indicate that the drug's activity increases with longer durations of drug exposure. Given its rapid half-life of two hours, the three-hour infusion could well be inadequate to give optimal exposure." He added that according to results of a recently completed trial, a 48% response rate was observed in 33 patients with relapsed breast cancer who were given a 96-hour infusion. "I am concerned that the general adoption of the three-hour schedule, which is bound to happen because of its convenience, could lead to a significant lowering of the response rate in ovarian and breast cancer patients," Chabner maintained. The FDA Oncology Drugs Advisory Committee recommended that Taxol be infused over three hours instead of 24 hours because they decided that the shorter infusion time would be less toxic and more convenient. The committee could not recommend a specific dose for Taxol. The FDA advisors based their decision on a study by the National Cancer Institute of Canada in relapsed ovarian cancer patients comparing three- and 24-hour schedules, at a dose of either 135 mg/m or 175 mg/m. The drug is currently labeled with a recommended dosage schedule of 135 mg/m over 24 hours. Bristol-Myers Squibb has submitted a supplemental NDA proposing that the regimen be changed to 175 mg/m over three hours. Chabner noted that patients who received 175 mg/m had a higher response rate in the Canadian study, while no difference was detected between the three-hour and 24-hour schedule when all doses were grouped together. However, he asserted that when individual parts of the trial were analyzed, the 175 mg/m at 24-hour schedule group had a 26% response rate, compared to a 19% response rate for the three-hour schedule at the same dose. He added that there were 80 patients in each arm of the study, "too few to allow detection of a significant difference" between the two schedules. NCI's Cancer Therapy Evaluation Program is planning to fund a contract to compare three- hour and 96-hour schedules of Taxol at maximum tolerated doses. The study, which is expected to begin soon, according to CTEP Director Michael Friedman, will probably be conducted at Memorial Sloan-Kettering Cancer Center and M.D. Anderson Cancer Center in a small number of relapsed breast cancer patients.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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