Pembrolizumab

Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.

Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.

Pembrolizumab is indicated for the following conditions: For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.

• Advanced Endometrial Cancer
• Advanced Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Locally Advanced Cutaneous Squamous Cell Carcinoma
• Locally Advanced or Metastatic Urothelial Carcinoma (UC)
• Metastatic Adenocarcinoma of the Gastroesophageal Junction
• Metastatic Cervical Cancer
• Metastatic Esophageal Carcinoma
• Metastatic Melanoma
• Metastatic Non-Small Cell Lung Cancer
• Metastatic Renal Cell Carcinoma ( mRCC)
• Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
• Metastatic Triple Negative Breast Cancers
• Metastatic Urothelial Carcinoma (UC)
• Metastatic cutaneous squamous cell carcinoma
• Metastic Renal Cell Carcinoma
• Non-Small Cell Lung Cancer (NSCLC)
• Nonsmall Cell Lung Cancer, Stage II
• Persistent Cervical Cancer
• Recurrent Cervical Cancer
• Refractory Primary Mediastinal Large B-Cell Cell Lymphoma
• Renal Cell Carcinoma (RCC)
• Resectable Non-small Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer
• Stage IIB Melanoma
• Stage IIC Melanoma
• Stage III Melanoma
• Stage IIIA Non Small Cell Lung Cancer
• Unresectable Melanoma
• Advanced Microsatellite Instability High Endometrial Carcinoma
• Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma
• High risk, early Triple Negative Breast Cancer
• High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG
• Locally advanced Adenocarcinomas of the Gastroesophageal Junction
• Locally advanced Esophageal Carcinoma
• Locally advanced Urothelial Carcinoma
• Metastatic HER2-positive Adenocarcinoma of the Stomach
• Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction
• Metastatic High Tumor Mutation Burden Solid Tumors
• Metastatic Merkel Cell Carcinoma (MCC)
• Metastatic Microsatellite Instability High Colorectal Cancer
• Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors
• Metastatic Mismatch Repair Deficient Colorectal Cancer
• Metastatic Mismatch repair deficient (dMMR) solid tumors
• Recurrent Cutaneous Squamous Cell Carcinoma
• Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction
• Recurrent, locally advanced Merkel Cell Carcinoma
• Refractory Classical Hodgkin's Lymphoma
• Relapsed Classical Hodgkin's Lymphoma
• Stage 3 Non-Small Cell Lung Carcinoma (NSCLC)
• Unresectable High Tumor Mutation Burden Solid Tumors
• Unresectable Microsatellite Instability High Colorectal Cancer
• Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors
• Unresectable Mismatch Repair Deficient Colorectal Cancer
• Unresectable Mismatch repair deficient (dMMR) solid tumors
• Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach
• Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction
• Unresectable, locally recurrent Triple Negative Breast Cancer
• Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)