Updated on 3 June 2015
Singapore: Global bio pharmaceutical company, Merck Sharp and Dohme, has received USFDA nod to review the supplemental biological license application of anti-PD-1 therapy, Keytruda, its non-small lung cancer drug.
Keytruda (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The FDA granted Priority Review with a PDUFA, or target action, date of October 2, 2015; the sBLA will be reviewed under the FDA's Accelerated Approval program.
"Today's announcement reflects our commitment to accelerate the development of immunotherapeutic approaches to treat lung cancer, one of the most deadly malignancies," said Dr Roger M. Perlmutter, president, Merck Research Laboratories.
"We believe that data submitted to the FDA illustrate the significant potential of Keytruda to treat advanced non-small cell lung cancer - and we look forward to working with the FDA to bring our anti-PD-1 therapy to patients afflicted with this devastating cancer."