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Keytruda FDA Approval History

Reviewed by Judith Stewart BPharm. Last updated on Oct 28, 2020.

FDA Approved: Yes (First approved September 4, 2014)
Brand name: Keytruda
Generic name: pembrolizumab
Dosage form: for Injection
Company: Merck
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Head and Neck Cancer, Hodgkin's Lymphoma, Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Small Cell Lung Cancer, Esophageal Carcinoma, Endometrial Cancer, Squamous Cell Carcinoma

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.

Indications

  • Melanoma
    • 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.
  • Non-Small Cell Lung Cancer (NSCLC)
    • in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
    • in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
    • 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.
    • 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. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.
  • Small Cell Lung Cancer (SCLC)
    • 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.1
  • Head and Neck Squamous Cell Cancer (HNSCC)
    • in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
    • 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.
    • as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing 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 after 2 or more lines of therapy.
  • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
    • for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy.1
    • Limitations of Use: Keytruda is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
  • Urothelial Carcinoma
    • 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.1
    • 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.
  • Microsatellite Instability-High or Mismatch Repair Deficient Cancer
    • 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,1 or
      • colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.1
    • Limitations of Use: The safety and effectiveness of Keytruda in pediatric patients with MSI-H central nervous system cancers have not been established.
  • Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)
    • for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
  • Gastric Cancer
    • 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.1
  • Esophageal Cancer
    • 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.
  • Cervical Cancer
    • 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.1
  • Hepatocellular Carcinoma (HCC)
    • for the treatment of patients with HCC who have been previously treated with sorafenib.1
  • Merkel Cell Carcinoma (MCC)
    • for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1
  • Renal Cell Carcinoma (RCC)
    • in combination with axitinib, for the first-line treatment of patients with advanced RCC.
      This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • Endometrial Carcinoma
    • 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.1
  • Tumor Mutational Burden-High (TMB-H) Cancer
    • 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.1
    • Limitations of Use: The safety and effectiveness of Keytruda in pediatric patients with TMB-H central nervous system cancers have not been established.
  • Cutaneous Squamous Cell Carcinoma (cSCC)
    • for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
  • Triple-Negative Breast Cancer (TNBC)
    • in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA approved test.2
  • Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks
    • for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications.2
1. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
2. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Development Timeline for Keytruda

DateArticle
Nov 13, 2020Approval FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)
Oct 15, 2020Approval FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
Jun 29, 2020Approval FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
Jun 24, 2020Approval FDA Approves Merck’s Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation
Jun 17, 2020Approval FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type
Apr 28, 2020Approval FDA Approves Merck’s Keytruda (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications
Jan  8, 2020Approval FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
Sep 17, 2019Approval FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma
Jul 31, 2019Approval FDA Approves Keytruda (pembrolizumab) for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
Jun 18, 2019Approval FDA Approves Keytruda (pembrolizumab) for the Treatment of Metastatic Small Cell Lung Cancer (SCLC)
Jun 11, 2019Approval FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma
Apr 22, 2019Approval FDA Approves Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC)
Apr 11, 2019Approval FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC
Feb 19, 2019Approval FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection
Dec 19, 2018Approval FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma
Nov  9, 2018Approval FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib
Oct 30, 2018Approval FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Aug 21, 2018Approval FDA Approves Expanded Label for Merck’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations
Jun 13, 2018Approval FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Jun 12, 2018Approval FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1
Sep 22, 2017Approval FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
May 23, 2017Approval FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature
May 18, 2017Approval FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma
May 10, 2017Approval FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression
Mar 15, 2017Approval FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)
Oct 24, 2016Approval FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer
Aug  5, 2016Approval FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Dec 18, 2015Approval FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
Oct  2, 2015Approval FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer
Sep  4, 2014Approval FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma
Sep  2, 2014Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab
Jun 30, 2014Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for Advanced Melanoma

Further information

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