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KEYTRUDA- pembrolizumab injection, powder, lyophilized, for solution
KEYTRUDA- pembrolizumab injection, solution
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE
1.1 Melanoma
KEYTRUDA� (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma [see Clinical Studies (14.1)].
1.2 Non-Small Cell Lung Cancer
KEYTRUDA is indicated 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) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations [see Clinical Studies (14.2)].
KEYTRUDA is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) 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 [see Clinical Studies (14.2)].
1.3 Head and Neck Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy [see Clinical Studies (14.3)].
