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FDA last week issued a draft guidance that urges sponsors to conduct randomized controlled trials when they seek accelerated approval.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?
FDA has been mulling over reliance on real-world evidence for about a decade, keeping it on the edges of the existing approval system that runs on data from conventional clinical trials.
Getting the dose right is not a mere formality but a fundamentally important first step that can mean the difference between success and failure of a drug development program, Richard Pazdur, director of the FDA Oncology Center of Excellence, said at a workshop focused on the issue of dose optimization.
