Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review. 

The proposed sBLA includes the use of Keytruda 200mg given intravenously (IV) every 3 weeks for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after 3 or more prior lines of therapy. Keytruda was granted Breakthrough Therapy Designation and Priority Review for this indication. Data from the KEYNOTE-087 and KEYNOTE-013 trials, which evaluated patients with refractory cHL or those who had relapsed after 3 or more lines of therapy, were used to support this sBLA. 

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Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, works by activating T-lymphocytes which may affect both tumor cells and healthy cells. It is approved to treat recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy; unresectable or metastatic melanoma; and 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. It is also approved to treat 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. 

The sBLA will be reviewed under the FDA’s accelerated approval program. FDA has set a target Prescription Drug User Fee Act (PDUFA) date of March 15, 2017. 

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