U.S. License Holder:

Merck Sharp Dohme

Date of License:

September-04-2014

FDA-Approved Indications

KEYTRUDA (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody indicated:

Melanoma: for the treatment of patients with unresectable or metastatic melanoma; for the adjuvant treatment of 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, as first-line treatment of patients with metastatic squamous NSCLC; as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) greater than or equal to 1 percent] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic; as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1 percent) 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;

Small Cell Lung Cancer (SCLC): For the treatment of 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 the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC; as a single agent for the first line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by an FDA-approved test; as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy;

Classical Hodgkin Lymphoma (cHL): for the treatment of 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 the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy;

Urothelial Carcinoma: for the treatment of 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) greater than or equal to 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant treatment with platinum-containing chemotherapy; for the treatment of 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 the treatment of 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 the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) greater than or equal to 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy;

Esophageal Cancer: for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to 10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy;

Cervical Cancer: for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by an FDA-approved test;

Hepatocellular Carcinoma (HCC): for the treatment o

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