The FDA Oncologic Drugs Advisory Committee voted overwhelmingly in favor of expanding the indications of two chimeric antigen receptor engineered T-cell therapies for multiple myeloma that showed improvement in progression-free survival, but also reported a higher number of early deaths on the experimental arm.Â
When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.
The FDA Oncologic Drugs Advisory Committee voted 12:2 to recommend approval of the drug imetelstat for a myelodysplastic syndrome indication.
FDA has directed the sponsors of CAR T-cell therapies to place boxed warnings on their products to indicate that the agents may cause secondary T-cell malignancies.Â
Multi-cancer detection tests evoke conflicting reactions—the excitement at their promise is quickly dampened by concerns over the uncertainty of their clinical benefit, very low sensitivity for detecting stage 1 cancers, and the risks that come from subsequent workups.
The FDA Oncologic Drugs Advisory Committee earlier this week was asked to review two of the slowest-moving confirmatory trials.
The FDA Oncologic Drugs Advisory Committee concurred with the FDA staff that the Amgen Inc. confirmatory trial of the lung cancer therapy sotorasib (Lumakras) was uninterpretable as a result of a perceived loss of equipoise.
The FDA Oncologic Drugs Advisory Committee Oct. 4 voted decisively to recommend the first-ever approval supported by a clinical trial that relied on an external control arm—using patient-level data extracted from another trial.
The FDA Oncologic Drugs Advisory Committee agreed with the agency’s forcefully stated view that Lynparza (olaparib), a PARP inhibitor, should be given only to metastatic castration-resistant prostate cancer patients whose tumors have a BRCA mutation.
Can data from one CAR T-cell therapy be used to inform FDA’s review of other CAR T products?
