Panobinostat’s Questionable Magnitude Of Benefit Can’t Outweigh Toxicities, Panel Says
This article was originally published in The Pink Sheet Daily
Novartis shouldn’t give up on drug for relapsed multiple myeloma, FDA’s Oncologic Drugs Advisory Committee says, even as panel votes against approval based on progression-free survival data.
You may also be interested in...
Lilly is positioning the ramucirumab/erlotinib combination as a first-line alternative for EGFR-positive non-small cell lung cancer that preserves AstraZeneca’s Tagrisso for second-line use; advisory committee members vote 6-5 for expanded indication but express skepticism about adoption.
Agency’s clinical experts favor granting access under regulations intended for investigational drugs but ‘lawyers want consistency under the law,’ FDA’s Woodcock says; use of the expanded access pathway for approved agents is generally unnecessary but may provide sponsors with some regulatory cover, external experts say.
US FDA declined stakeholder requests to remove recommendation for placebo controls from a final guidance but added qualifying language on their use ‘when feasible.’ While the agency excised language on biomarker validation from the final guidance, it reaffirmed the need for early establishment of critical quality attributes and critical process parameters.