Patient Voices Swayed FDA's Imlygic Review Team
Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.
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Case Studies In FDA's Regulatory Interpretation Of Clinical Trials
For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.
Choice Of Regulatory Pathway Is Key Inflection Point In Drug Reviews
A year of Drug Review Profiles in the Pink Sheet shows how important the choice of regulatory pathway has become to drug development and approval.
Oncology PROs: Limited Use Due To Small Trials, Fast Drug Development
Patient-reported outcomes in oncology clinical trials remain an infrequently used tool, despite acknowledgement by sponsors that the patient experience is important to measure – and encouragement from FDA officials to do so. The lack of PROs in oncology may be a byproduct of the fast pace of cancer drugs are developed in the U.S.: small trials and accelerated pathways.