FDA Grants Priority Review to Pembrolizumab + Chemo sBLA for NSCLC
The FDA has granted Priority Review to Merck's sBLA for pembrolizumab (Keytruda) in combination with chemotherapy.
The U.S. Food and Drug Administration (FDA) has granted Priority Review to Merck's supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) in combination with chemotherapy for the first-line treatment metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations.1
This sBLA submission, which seeks accelerated approval for pembrolizumab at a fixed dose of 200 mg administered intravenously in combination with pemetrexed 500 mg/m2 and carboplatin AUC 5 mg/mL/min every 3 weeks for 4 cycles, is based on findings from part 2, cohort G of the KEYNOTE-021 trial (ClinicalTrials.gov Identifier: NCT02039674).
The study, which was presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, showed that the addition of pembrolizumab to pemetrexed and carboplatin significantly reduced the risk of progression by 47% compared with pemetrexed plus carboplatin alone (hazard ratio, 0.53; 95% CI, 0.31-0.91; P = .0102). Median progression-free survival was 13.0 months with pembrolizumab vs 8.9 months in the control group.
Under the FDA's Accelerated Approval program, the FDA set a target action date of May 10, 2017 for the sBLA.
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Pembrolizumab is approved for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or greater), with no EGFR or ALK genomic tumor aberrations, as well as for patients with metastatic NSCLC whose tumors express PD-L1 (TPS of 1% or more), with disease progression on or after platinum-containing chemotherapy.
- Merck receives FDA acceptance of supplemental Biologics License Application for Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer. Merck website. http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-fda-acceptance-supplemental-biologics-license-applicat. Published January 10, 2017. Accessed January 12, 2017.