Home > Newsletters > FDAnews Drug Daily Bulletin > FDA Guidance Could Propel Breast Cancer Drugs to Market a Decade Sooner
FDAnews Drug Daily Bulletin
May 31, 2012 | Vol. 9 No. 107
FDA Guidance Could Propel Breast Cancer Drugs to Market a Decade Sooner
Drugmakers could bring breast cancer treatments to market a decade earlier with new FDA guidance on trial designs for evaluating pathologic complete response (pCR) to support accelerated approval of drugs to treat high-risk, early-stage breast cancer. By using randomized neoadjuvant trials assessing a pCR endpoint, sponsors may be reasonably likely to predict clinical benefit within several months of initiating treatment with an investigational drug, the FDA said in a Tuesday draft guidance.
Drug Industry Daily
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.