Pembrolizumab

Pembrolizumab is an antibody that blocks programmed death receptor-1 (PD-1). It is indicated in the following conditions. Melanoma: for patients with unresectable or metastatic melanoma. It is also used as adjuvant treatment for patients with melanoma with involvement of lymph node(s) following complete resection. Non-Small Cell Lung Cancer (NSCLC): in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. In combination with carboplatin and either paclitaxel or paclitaxel protein-bound, it is used as first-line treatment of patients with metastatic squamous NSCLC. As a single agent, it is used for first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and who have stage III disease and are not candidates for surgical resection or definitive chemoradiation, or who have metastatic disease. As a single agent, it is also used for 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 before receiving Pembrolizumab. Small Cell Lung Cancer (SCLC): for patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Head and Neck Squamous Cell Cancer (HNSCC): in combination with platinum and FU, for first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. As a single agent, it is used for first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. As a single agent, it is also used for patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma (cHL): for adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy. Primary Mediastinal Large B-Cell Lymphoma (PMBCL): for adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. Urothelial Carcinoma: for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. It is also used for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. And it is used for patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High Cancer: for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Gastric Cancer: for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy. Esophageal Cancer: for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. Cervical Cancer: for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. Hepatocellular Carcinoma (HCC): for patients with HCC who have been previously treated with sorafenib. Merkel Cell Carcinoma (MCC): for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. Renal Cell Carcinoma (RCC): in combination with axitinib, for first-line treatment of patients with advanced RCC. Endometrial Carcinoma: in combination with lenvatinib, for patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.