The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
FDA issued Complete Response Letters for the Biologics License Application for odronextamab in relapsed/refractory follicular lymphoma and in R/R diffuse large B-cell lymphoma, each after two or more lines of systemic therapy.
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.
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.
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.
