PPIDT00255
Drug Information
| Name | Pembrolizumab |
|---|---|
| Sequence | QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNFNEKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK |
| DrugBank_ID | DB09037 |
| Type | biotech |
| Indication | Pembrolizumab is indicated for the following conditions:[L48641,L44868,L43488] ### Melanoma - for the treatment of patients with unresectable or metastatic melanoma (adult patients in the US[L38934] and patients ≥12 years old in the EU)[L43488] - for the adjuvant treatment of adult and pediatric patients 12 years of age and older with Stage IIB, IIC, or III melanoma following complete resection ### Non-Small Cell Lung Cancer (NSCLC) - in combination with [pemetrexed] and platinum-based chemotherapy as a first-line treatment for patients with metastatic nonsquamous NSCLC with no EGFR or ALK mutations - in combination with [carboplatin] and [paclitaxel] as a first-line treatment for patients with metastatic squamous NSCLC - as a monotherapy for the first-line treatment of NSCLC expressing PD-L1 with no EGFR or ALK mutations in patients with metastatic disease or stage III disease who are not candidates for surgery or chemoradiation - as a monotherapy for the treatment of NSCLC expressing PD-L1 with disease progression on or after platinum-based chemotherapy - this includes patients with EGFR or ALK mutations, providing they have experienced disease progression on prior FDA-approved therapy for these aberrations - in combination with platinum-based chemotherapy for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery ### Malignant Pleural Mesothelioma (MPM) - in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment in adult patients with unresectable advanced or metastatic MPM ### Head and Neck Squamous Cell Cancer (HNSCC) - in combination with [fluorouracil] and platinum-based chemotherapy as a first-line treatment for patients with metastatic or recurrent, unresectable HNSCC - as a monotherapy for the first-line treatment of patients with metastatic or recurrent, unresectable HNSCC expressing PD-L1 - as a monotherapy for the treatment of patients with metastatic or recurrent HNSCC with disease progression on or after platinum-based 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 following ≥2 lines of therapy ### Primary Mediastinal Large B-cell Lymphoma (PMBCL) - for the treatment of adult and pediatric patients with refractory PMBCL, or PMBCL that has relapsed following ≥2 lines of therapy ### Urothelial Carcinoma - for the treatment of locally advanced or metastatic urothelial carcinoma in patients ineligible for platinum-based chemotherapy - for the treatment of locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-based chemotherapy or within 12 months of adjuvant/neoadjuvant platinum-based chemotherapy - for the treatment of [BCG vaccine]-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors, who are not candidates for cystectomy - for the treatment of locally advanced or metastatic urothelial carcinoma in combination with enfortumab vedotin in adult patients ineligible for platinum-based chemotherapy under the accelerated approval from the FDA ### Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient Cancer (dMMR) - as a last-line therapy for the treatment of adult and pediatric patients with unresectable or metastatic MSI-H or dMMR solid tumors that have progressed following prior treatment - for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer ### Gastric Cancer - in combination with [trastuzumab], fluoropyrimidine-, and platinum-containing chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD -L1 (CPS ≥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 - in combination with fluoropyrimidine- and platinum-based chemotherapy for the treatment of patients with locally advanced or metastatic esophageal or GEJ carcinoma who are not candidates for surgery or definitive chemoradiation - as a monotherapy for the treatment of locally advanced or metastatic esophageal or GEJ carcinoma expressing PD-L1 in patients who are not candidates for surgery or definitive chemoradiation ### Cervical Cancer - in combination with other chemotherapies, with or without [bevacizumab], for the treatment of persistent, recurrent, or metastatic cervical cancer expressing PD-L1 - as a monotherapy for the treatment of recurrent or metastatic cervical cancer expressing PD-L1 in patients who have experienced disease progression on or after previous chemotherapy - in combination with chemoradiotherapy for the treatment of patients with FIGO 2014 Stage III -IVA cervical cancer ### Hepatocellular Carcinoma (HCC) - as a monotherapy for the treatment of HCC in patients who have been previously treated with [sorafenib] ### 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 MCC ### Renal Cell Carcinoma (RCC) - in combination with either [axitinib] or [lenvatinib] as a first-line treatment for adult patients with advanced RCC - for the adjuvant treatment of patients with RCC who are at an 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 pembrolizumab as a single agent, for the t reatment 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 not MSI-H or dMMR who experience disease progression following prior systemic therapy and who are not candidates for surgery or radiation therapy - as a monotherapy for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation ### Tumor Mutational Burden-High (TMB-H) Cancer - as a last-line therapy for the treatment of adult and pediatric patients with unresectable or metastatic TMB-H solid tumors that have progressed following prior treatment ### Cutaneous Squamous Cell Carcinoma (cSCC) - for the treatment of patients with recurrent or metastatic sCC, or locally advanced sCC that is not curable with surgery or radiation therapy ### Triple-Negative Breast Cancer (TNBC) - for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as a neoadjuvant treatment followed by continued use as a single adjuvant agent following surgery - in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic TNBC expressing PD-L1 For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.[L38934] |
Dosage Forms
| Form | Route | Strength |
|---|---|---|
| Injection, powder, for solution | Intravenous |
50 mg
|
| Injection, powder, for solution | Intravenous; Parenteral |
50 MG
|
| Injection, powder, lyophilized, for solution | Intravenous |
50 mg/2mL
|
| Injection, solution | Intravenous |
25 mg/1mL
|
| Injection, solution | Intravenous |
50 mg/1vial
|
| Injection, solution, concentrate | Intravenous |
25 MG/ML
|
| Injection; injection, solution | Intravenous |
25 MG/ML
|
| Powder, for solution | Intravenous |
50 mg / vial
|
| Solution | Intravenous |
100.000 mg
|
| Solution | Intravenous |
25 mg / mL
|
| Injection, solution | Intravenous |
100 mg/4ml
|
| Solution | Intravenous |
25.0 mg/mL
|
| Solution | Intravenous |
100 mg
|
| Solution | Intravenous |
10000000 mg
|