Keytruda

Chemical Namepembrolizumab
Dosage FormInjection (intravenous; 100 mg/4 mL (25 mg/mL))
Drug ClassProgrammed death receptor-1-blocking antibodies
SystemMultiple
CompanyMerck & Co.
Approval Year2014

Indication

  • 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.
  • Indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
  • Indicated in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
  • Indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
  • Indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.
  • Indicated in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell cancer (HNSCC).
  • Indicated 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) ≥1] as determined by an FDA-approved test.
  • Indicated as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
  • For the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
  • For the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
  • For the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
  • 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 or adjuvant 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.
  • For the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.
  • For the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
  • Indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  • 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 as 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 ≥10) as determined by an FDA-approved test.
  • Indicated 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 ≥1) as determined by an FDA-approved test.
  • Indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
  • For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • For the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
  • Indicated in combination with axitinib, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
  • Indicated 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.
  • Indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
  • Indicated 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.
  • For the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥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.
  • For the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.
  • 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.
  • Indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
Last updated on 11/14/2022

More on this drug: Clinical Trials

Document TitleYearSource
Keytruda (pembrolizumab) Prescribing Information.2022Merck & Co., Whitehouse Station, NJ
Document TitleYearSource
Efficacy and safety of pembrolizumab based therapies in triple-negative breast cancer: a systematic review of clinical trials 2021Critical Reviews in Oncology / Hematology
Comparative efficacy and safety of PD-1/PD-L1 inhibitors for patients with solid tumors: a systematic review and Bayesian network meta-analysis. 2021Journal of Cancer
First-line treatment of metastatic renal cell carcinoma in the immuno-oncology era: systematic review and network meta-analysis.2020Clinical Genitourinary Cancer
Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review.2020Therapeutic Advances in Medical Oncology
Systemic therapy for metastatic renal cell carcinoma in the first‑line setting: a systematic review and network meta‑analysis.2020Cancer Immunology, Immunotherapy
Nivolumab plus ipilimumab versus existing immunotherapies in patients with PD-L1-positive advanced non-small cell lung cancer: a systematic review and network meta-analysis.2020Cancers
Single or combined immune checkpoint inhibitors compared to first‐line platinum‐based chemotherapy with or without bevacizumab for people with advanced non‐small cell lung cancer.2020Cochrane Database of Systematic Reviews
Cost effectiveness of immune checkpoint inhibitors for treatment of non-small cell lung cancer: a systematic review.2020PLoS One
What is the optimum systemic treatment for advanced/metastatic renal cell carcinoma of favourable, intermediate and poor risk, respectively? A systematic review and network meta-analysis.2020BMJ Open
Efficacy and safety of immune checkpoint inhibitors in patients with advanced non–small cell lung cancer (NSCLC): a systematic literature review.2020OncoImmunology
Targeted therapy for metastatic renal cell carcinoma.2020Cochrane Database of Systematic Reviews
Comparative efficacy of first-line immune-based combination therapies in metastatic renal cell carcinoma: a systematic review and network meta-analysis.2020Cancers
Economic evaluation of systemic treatments for advanced melanoma: a systematic review.2020Value in Health
Immune checkpoint inhibitors and immune-related adverse events in patients with advanced melanoma: a systematic review and network meta-analysis.2020JAMA Network
Hepatotoxicity in patients with solid tumors treated with PD-1/PD-L1 inhibitors alone, PD-1/PD-L1 inhibitors plus chemotherapy, or chemotherapy alone: systematic review and meta-analysis.2020European Journal of Clinical Pharmacology
Immune checkpoint inhibitors in advanced acral melanoma: a systematic review.2020Frontiers in Oncology
Immune-checkpoint inhibitor plus chemotherapy versus conventional chemotherapy for treatment of recurrent or metastatic head and neck squamous cell carcinoma: a systematic review and network meta-analysis.2020Therapeutic Advances in Medical Oncology
First-line treatments for advanced renal-cell carcinoma with immune checkpoint inhibitors: systematic review, network meta-analysis and cost-effectiveness analysis.2020Therapeutic Advances in Medical Oncology
A systematic review and meta-analysis of immune-related adverse events of anti-PD-1 drugs in randomized controlled trials.2020Technology in Cancer Research & Treatment
Systematic review and network meta-analysis of immune checkpoint inhibitors in combination with chemotherapy as a first-line therapy for extensive-stage small cell carcinoma.2020Cancers
Immune checkpoint inhibitors, alone or in combination with chemotherapy, as first-line treatment for advanced non-small cell lung cancer. A systematic review and network meta-analysis.2019Lung Cancer
Treatment-related adverse events of PD-1 and PD-L1 Inhibitors in clinical trials: a systematic review and meta-analysis.2019JAMA Oncology
Pembrolizumab plus chemotherapy for first-line treatment of metastatic nonsquamous non-small-cell lung cancer: a network meta-analysis.2019Immunotherapy
The landscape of immune checkpoint inhibitor plus chemotherapy versus immunotherapy for advanced non‐small‐cell lung cancer: a systematic review and meta‐analysis.2019Journal of Cellular Physiology
A systematic literature review and network meta-analysis of effectiveness and safety outcomes in advanced melanoma.2019European Journal of Cancer
Comparative efficacy and safety of immunotherapies targeting the PD-1/PD-L1 pathway for previously treated advanced non-small cell lung cancer: a Bayesian network meta-analysis.2019Critical Reviews in Oncology / Hematology
First-line pembrolizumab versus pembrolizumab plus chemotherapy versus chemotherapy alone in non-small-cell lung cancer: a systematic review and network meta-analysis.2019Clinical Lung Cancer
Risk of pneumonitis and pneumonia associated with immune checkpoint inhibitors for solid tumors: a systematic review and meta-analysis.2019Frontiers in Immunology
Role of immune checkpoint inhibitor-based therapies for metastatic renal cell carcinoma in the first-line setting: a Bayesian network analysis.2019EBioMedicine
Comparative efficacy of second- and subsequent-line treatments for metastatic NSCLC: a fractional polynomials network meta-analysis of cancer immunotherapies.2019Clinical Lung Cancer
First-line treatment for patients with advanced non-small cell lung carcinoma and high PD-L1 expression: pembrolizumab or pembrolizumab plus chemotherapy.2019Journal for ImmunoTherapy of Cancer
First-line immune checkpoint inhibitors for advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK): a systematic review and network meta-analysis.2019Journal of Thoracic Disease
The differences in the safety and tolerability of immune checkpoint inhibitors as treatment for non-small cell lung cancer and melanoma: network meta-analysis and systematic review.2019Frontiers in Pharmacology
Chemotherapy in combination with immune checkpoint inhibitors for the first-line treatment of patients with advanced non-small cell lung cancer: a systematic review and literature-based meta-analysis.2019Frontiers in Oncology
Comparison of immune checkpoint inhibitors between older and younger patients with advanced or metastatic lung cancer: a systematic review and meta-analysis.2019BioMed Research International
Comparative analysis of immune checkpoint inhibitors and chemotherapy in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized controlled trials.2018Medicine
Looking for the best immune-checkpoint inhibitor in pre-treated NSCLC patients: an indirect comparison between nivolumab, pembrolizumab and atezolizumab.2018International Journal of Cancer
A systematic review of the cost and cost-effectiveness studies of immune checkpoint inhibitors.2018Journal for ImmunoTherapy of Cancer
Comparative safety of immune checkpoint inhibitors in cancer: systematic review and network meta-analysis.2018BMJ
Immune-related adverse events for anti-PD-1 and anti-PD-L1 drugs: systematic review and meta-analysis.2018BMJ
The risk of immune-related endocrine disorders associated with anti-PD-1 inhibitors therapy for solid tumors: a systematic review and meta-analysis.2018International Immunopharmacology
Pembrolizumab monotherapy versus chemotherapy for treatment of advanced urothelial carcinoma with disease progression during or following platinum-containing chemotherapy. 2018Cochrane Database of Systematic Reviews
Safety and tolerability of PD-1/PD-L1 inhibitors compared with chemotherapy in patients with advanced cancer: a meta-analysis.2017The Oncologist
Document TitleYearSource
Follow-up and management of checkpoint inhibitor related toxicities in cancer patients.2022Alberta Health Services
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events.2021Journal for ImmunoTherapy of Cancer
Metastatic colorectal cancer.2021Alberta Health Services
Gastric cancer.2021Alberta Health Services
Renal cell carcinoma.2021Alberta Health Services
Locally advanced/metastatic bladder cancer.2021Alberta Health Services
Argentinian clinical practice guideline for surveillance, diagnosis, staging and treatment of hepatocellular carcinoma.2020Annals of Hepatology
Systemic therapy for advanced hepatocellular carcinoma: ASCO guideline.2020Journal of Clinical Oncology
Systemic therapy for melanoma: ASCO guideline.2020Journal of Clinical Oncology
SEOM clinical guideline for treatment of muscle-invasive and metastatic urothelial bladder cancer (2018).2019Clinical and Translational Oncology
Merkel cell carcinoma.2019Alberta Health Services
Lymphoma. 2019Alberta Health Services
Management of toxicities from immunotherapy: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.2019Annals of Oncology
Metastatic pancreatic cancer: ASCO clinical practice guideline update.2018Journal of Clinical Oncology
Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update.2017Journal of Clinical Oncology
Bladder cancer, version 5.2017, NCCN clinical practice guidelines in oncology.2017Journal of the National Comprehensive Cancer Network
Non-small cell lung cancer, version 5.2017, NCCN clinical practice guidelines in oncology.2017Journal of the National Comprehensive Cancer Network