Biotech Values

[JohnWayne]

MRK - FDA Accepts sBLA for Keytruda + Chemo in 1L NSCLC

PDUFA set for May 10th. Based on Phase 2 KEYNOTE-021 study that was presented at ESMO last year, sounds like it will be a broad label with no patient selection by PD-L1 status. This is huge for Merck.

http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-fda-acceptance-supplemental-biologics-license-applicat


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

Submission Based on Data from KEYNOTE-021 Trial, Cohort G, Which Enrolled Patients Regardless of PD-L1 Expression
Tuesday, January 10, 2017 4:06 pm EST
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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with 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.

This is the first application for regulatory approval of KEYTRUDA in combination with another treatment. The FDA granted Priority Review with a PDUFA, or target action, date of May 10, 2017. The sBLA will be reviewed under the FDA’s Accelerated Approval program.

“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “KEYTRUDA in combination with chemotherapy has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”

The application seeks accelerated approval for KEYTRUDA at a fixed dose of 200 mg administered intravenously every three weeks in combination with pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes every three weeks, and carboplatin AUC 5 mg/mL/min every three weeks for four cycles. KEYNOTE-021, Part 2, Cohort G, the pivotal cohort that forms the basis of the submission, studied 123 previously untreated patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and regardless of PD-L1 expression.