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 adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma 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; for the treatment of patients with resectable (tumors greater than or equal to 4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC;

Malignant Pleural Mesothelioma (MPM): in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM;

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 patients with relapsed or refractory cHL; for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more 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 Cancer: in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer; as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant treatment with platinum-containing chemotherapy; as a single agent 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 or Mismatch Repair Deficient Cancer: for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options;

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC): for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test;

Gastric Cancer: in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS greater than or equal to 1) as determined by an FDA-approved test; In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma;

Esophageal Cancer: for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy, or s a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS greater than or equal to 10) as determined by an FDA-approved test;

Cervical Cancer: In combination with chemoradiotherapy, for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer; in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (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 metastaticcervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS greater than or equal to 1) as determined by an FDA-approved test;

Hepatocellular Carcinoma (HCC): for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen;

Biliary Tract Cancer (BTC): In combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer;

Merkel Cell Carcinoma (MCC): for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma;

Renal Cell Carcinoma (RCC): In combination with axitinib, for the first-line treatment of adult patients with advanced RCC; In combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC; For the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions;

Endometrial Carcinoma: In combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma; In combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; As a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation;

Tumor Mutational Burden-High (™B-H) Cancer: For the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (™B-H) [greater than or equal to 10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options;

Cutaneous Squamous Cell Carcinoma (cSCC): For the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer (TNBC): For the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; In combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS greater than or equal to 10) as determined by an FDA approved test;

Adult Classical Hodgkin Lymphoma and Adult Primary Mediastinal Large B-Cell Lymphoma: Additional Dosing Regimen of 400 mg Every 6 Weeks: For use at an additional recommended dosage of 400 mg every 6 weeks for Classical Hodgkin Lymphoma and Primary Mediastinal Large B-Cell Lymphoma in adults.

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