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The Oncologic Drugs Advisory Committee in a Sept. 26 meeting will discuss whether the regulator should restrict approval of checkpoint inhibitors based on PD-L1 expression levels.
An FDA advisory committee agreed on Friday that Zevra Therapeutics had provided sufficient efficacy data supporting the approval of arimoclomol for Niemann-Pick disease type C.
The Genetic Metabolic Diseases Advisory Committee will meet on Friday to discuss Zevra’s modified scale to describe the efficacy of its drug candidate for the treatment of Niemann-Pick disease type C.
The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
The FDA’s Oncologic Drugs Advisory Committee on Thursday strongly supported changing clinical trials for non-small cell lung cancer drugs given in the perioperative setting, pointing out the need for a more nuanced approached to treatments before and after surgery.
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
The Institute for Clinical and Economic Review has again flagged “substantial concerns” with Lykos Therapeutics’ data for its MDMA-based therapy for post-traumatic stress disorder and propensity for bias.
The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.