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

UsernamePublicRestriction
UsernamePublicRestriction

BONE PAIN REDUCTION COULD BE ADDITIONAL EFFICACY CRITERIA FOR CANCER AGENTS, FDA

Executive Summary

BONE PAIN REDUCTION COULD BE ADDITIONAL EFFICACY CRITERIA FOR CANCER AGENTS, FDA Office of Drug Research and Review Director Robert Temple, MD, suggested at a June 28 Oncologic Drugs Advisory Cmte. meeting. Asking the cmte. what responses other than tumor shrinkage could be meaningful in terms of determining efficacy of a cancer agent, Temple suggested that bone pain might be one possible parameter. "The things that come to mind as, possibly, symptoms whose improvement would unequivocally represent a real drug effect are things like bone pain over site of evident metastasis, a change in appetite accompanied by an increase in nonfluid weight in a patient who had been obviously cachectic, perhaps an improvement in pulmonary function in a person who did not have a lung infection but did have identified pulmonary metastases, and things of that nature," Temple stated. Temple explained that "the purpose of identifying those things is to provide within a study -- that is, without reference to any external conclusions about how you think the active control works -- unequivocal evidence of a benefit to the patient." The reason, Temple continued, "one needs parameters like that as opposed to making use of quality-of-life scores is that it seems possible that quality-of-life scores are affected by a variety of influences, only some of which might be the tumor." Because cancer trials typically use an active control, Temple explained, "a showing of no difference in survival between the new agent and the control agent does not in fact prove anything about whether either agent had an effect on survival." Temple noted, "it is fairly apparent that an approval of such an application on the basis of that kind of trial would, in effect, be an approval based on [tumor] response rate." He added: "That is not necessarily an invalid criterion." While the cmte. came to no firm conclusions, cmte. member Susan Pitman, Md, Yale University School of Medicine, New Haven, Connecticut, commented: "I think things are going in the right direction . . . I think your suggestion that, in addition to objective tumor response or shrinkage, we have some other parameter, possibly, to add to that, to somehow assess the subjective improvement of the patient, is not a bad idea."

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

UsernamePublicRestriction

Register

MT142464

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