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.
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?
FDA last week issued a draft guidance that urges sponsors to conduct randomized controlled trials when they seek accelerated approval.
The FDA Oncologic Drugs Advisory Committee March 9 voted 11:2 in favor the approval of Polivy (polatuzumab vedotin-piiq) in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for treatment-naive diffuse large B-cell lymphoma.
Can a single drug replace a long-established curative, albeit brutal, regimen of chemotherapy, radiation, and surgery?
