Genentech’s Perjeta Gets FDA Panel Nod, But With “Some Words Of Advice”
This article was originally published in The Pink Sheet Daily
Executive Summary
Oncologic Drugs Advisory Committee members backing a claim for neoadjuvant treatment of early breast cancer cite pertuzumab’s special circumstances in cautioning that they are not opening the door wide to accelerated approval of other agents under an FDA draft guidance. And the panel chairman urges the company to “avoid a repeat performance of Avastin.”
You may also be interested in...
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.
US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects
CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.