FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Metastatic NSCLC for First-Line Treatment of Patients Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] of 50 Percent or More) With No EGFR or ALK Genomic Tumor Aberrations
KEYTRUDA is the Only Anti-PD-1 Therapy Approved in First-Line Treatment of Metastatic NSCLC; KEYTRUDA Demonstrated Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Expressed High Levels of PD-L1
FDA Also Approves a Labeling Update for KEYTRUDA for the Treatment of Patients with Metastatic NSCLC Whose Tumors Express PD-L1 (TPS of One Percent or More) With Disease Progression On or After Platinum-Containing Chemotherapy; Patients With EGFR or ALK Genomic Tumor Aberrations Should Have Disease Progression On FDA-Approved Therapy for These Aberrations Prior to Receiving KEYTRUDA
KENILWORTH, N.J., Oct. 24, 2016 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1)therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. With this new indication, KEYTRUDA is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients. In addition, the FDA approved a labeling update to include data from KEYNOTE-010 in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1 (TPS of one percent or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. In metastatic NSCLC, KEYTRUDA is approved for use at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
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