Keytruda

Chemical Namepembrolizumab
Dosage FormInjection (intravenous; 50 mg lyophilized powder in single-dose vial for reconstitution, 100 mg/4 mL (25 mg/mL) solution in a single-dose vial)
Drug ClassMonoclonal antibodies
SystemSkin, Respiratory, Blood, Digestive, Urinary, Female reproductive
CompanyMerck & Co.
Approval Year2014

Indication

  • For the treatment of patients with unresectable or metastatic melanoma.
  • For the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • Used as a first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations in combination with pemetrexed and platinum chemotherapy.
  • Used as a first-line treatment of patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or paclitaxel protein-bound.
  • Used 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.
  • Used 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.
  • For the treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
  • Used as a first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC in combination with platinum and FU.
  • Used 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.
  • Used 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 and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy.
  • For the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. Not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma 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 solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
  • For the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
  • For the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
  • For the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
  • For the treatment of patients with 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.
  • For the first-line treatment of patients with advanced RCC in combination with axitinib.
  • Used 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 and are not candidates for curative surgery or radiation.
Last updated on 4/19/2021

More on this drug: Clinical Trials

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Document TitleYearSource
Keytruda (pembrolizumab) Prescribing Information2014Merck & 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