Pembrolizumab 100mg/50ml in Sodium chloride 0.9% infusion bags

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
- as a monotherapy for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB, II, or IIIA NSCLC

### 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)
- as a monotherapy in adult patients with resectable locally advanced HNSCC, first as neoadjuvant treatment, then continued as adjuvant treatment in combination with radiotherapy with or without cisplatin, and then again as a single agent
- 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 Cancer
- 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
- in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for [cisplatin]-containing chemotherapy

### 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 locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic side wall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs

### Hepatocellular Carcinoma (HCC)
- as a monotherapy for the treatment of 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 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]


The subcutaneous formulation of pembrolizumab (Keytruda QLEX) is indicated across most solid tumor indications for the intravenous formulation.
[L54021]