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?
CAR T-cell therapies have been used to treat cancer patients since 2011, but infection-related adverse events remain a significant hurdle. Often, fever is one of the earliest warning signs of clinical deterioration and a potentially life-threatening condition.
FDA approved the Premarket Approval application for xT CDx, a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
FDA released a draft guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” to support the use of decentralized clinical trials for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
FDA accepted the supplemental Biologics License Application sBLA and the European Medicines Agency has validated the Type II Variation Application for Reblozyl (luspatercept-aamt) to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions.
FDA granted Fast Track designation for ¹⁷⁷Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer.
This week, Federal Judge Kacsmaryk of Northern District of Texas concluded that the FDA erred in 2000 when it granted Accelerated Approval to mifepristone as an agent to facilitate a medical abortion.
Pragmatica-Lung, the first study born from a broader effort by NCI, FDA, industry, academia, and advocacy groups to modernize the clinical trial process, has begun enrolling patients.
FDA last week issued a draft guidance that urges sponsors to conduct randomized controlled trials when they seek accelerated approval.
