Keytruda Bladder Cancer Advisory Cmte. To Discuss Clinical Meaningfulness Of Complete Response Rate
US FDA's questions about Keytruda's increased response rate in Merck's study compared to the historical control were raised in a new point-counterpoint advisory committee briefing document format.
You may also be interested in...
Heading into an advisory committee review, agency suggests belantamab’s risks of keratopathy and other ocular issues have not been fully characterized and questions whether the proposed mitigation measures, including dosing modifications, are adequate.
ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week.
Many Oncologic Drugs Advisory Committee members struggled to decide whether the data showed a clinically meaningful benefit in the proposed bladder cancer indication.