FDA to Review Study Data for Keytruda NSCLC Indication
Merck announced that the Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) to include data from the Phase 2/3 study KEYNOTE-010 for the treatment of metastatic non-small cell lung cancer (NSCLC).
KEYNOTE-010 was a pivotal study evaluating Keytruda vs. chemotherapy based on prospective measurement of PD-L1 expression in previously treated patients with advanced NSCLC. Findings from this study were presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress and published in The Lancet in December 2015.
The NSCLC indication for Keytruda was approved under accelerated approval. Data from KEYNOTE-010 was intended to serve as the confirmatory trial for receiving full approval, establishing the clinical benefit of Keytruda by demonstrating improved survival over standard chemotherapy.
Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody. It is currently indicated for the treatment of patients with unresectable or metastatic melanoma and for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.
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