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Name
Keytruda
Alternate Names
MK-3475
SCH 900475
lambrolizumab
pembrolizumab
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
monoclonal antibody
NSC Number
None
Primary Site
See remarks
testing
Histology
Melanoma, NSCLC, Hodgkin lymphoma, urothelial carcinoma, GI adenocarcinoma, Merkle cell carcinoma, mesothelioma
Remarks
September 17, 2024, the FDA approved pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
June 17, 2024 FDA approved pembrolizumab (Keytruda) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.
January 12, 2024 FDA approved pembrolizumab (Keytruda) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.
November 16, 2023 FDA approved pembrolizumab (Keytruda) 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.
October 31, 2023 The FDA approved pembrolizumab (Keytruda) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).
October 16, 2023 The FDA approved pembrolizumab (Keytruda) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
April 3, 2023 FDA approved Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. 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.
This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the United States for these patients.
March 31, 2023 FDA granted full approval to Keytruda for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.
January 27, 2023 FDA approved Keytruda (pembrolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for stage 1B, 2, or 3A non-small cell lung cancer.
November 12, 2021 FDA approved the anti-PD-1 therapy Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
10/13/2021 The FDA approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.
9/3/2021 Keytruda plus Lenvima have received FDA approval as first-line treatment of adult patients with advanced renal cell carcinoma. Coding note: code each agent in the appropriate treatment field: BRM for Keytruda, chemo for Lenvima.
7/9/2021 Keytruda has received an expanded label approval from FDA as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation
7/21/2021 The FDA approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
7/26/2021 The FDA approved pembrolizumab (Keytruda) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
May 5, 2021 The FDA granted accelerated approval to pembrolizumab (Keytruda) 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
March 22, 2021: FDA approved pembrolizumab (Keytruda), in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation
November 13, 2020: The FDA granted accelerated approval to pembrolizumab (KEYTRUDA) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
October 16, 2020: Keytruda (pembrolizumab) has received an expanded label use from FDA as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.
FDA also approved an updated pediatric indication for Keytruda for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy.
6/29/2020 The FDA approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy
6/24/2020 The FDA approved pembrolizumab (KEYTRUDA) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation
6/19/2020 Keytruda was approved by FDA as monotherapy 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, regardless of tumor type.
June 16, 2020: The FDA granted accelerated approval to pembrolizumab (KEYTRUDA) 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.
January 8, 2020 The FDA approved pembrolizumab (KEYTRUDA) 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.
9/20/2019 FDA has granted accelerated approval to the combination of Merck’s Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
July 30, 2019 FDA approves pembrolizumab for advanced esophageal squamous cell cancer
June 10, 2019: FDA approved pembrolizumab (KEYTRUDA) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
April 19, 2019: FDA approved pembrolizumab (KEYTRUDA) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
February 15, 2019 FDA approved pembrolizumab (KEYTRUDA, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
12/19/2018 FDA granted accelerated approval to pembrolizumab (KEYTRUDA) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
November 9, 2018: FDA granted accelerated approval to pembrolizumab (KEYTRUDA) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
October 30, 2018: FDA approved pembrolizumab (KEYTRUDA) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).
August 17, 2018: FDA approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations. .
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda®) for 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
9/29/2017: FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, 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 two or more prior lines of therapy including fluoropyrimidine-and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
6/15/2018: FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy.
5/23/217: FDA granted accelerated approval to pembrolizumab for 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 or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. May 23, 2017.
5/18/2017: FDA granted regular approval to pembrolizumab (KEYTRUDA) for 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.
5/10/2017: The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).
3/17/2017: FDA granted an accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
September 2014 FDA granted accelerated approval to pembrolizumab for treatment of patients with unresectable or metastatic melanoma and disease progression.
Update to September 2014 announcement: Final FDA approval granted to Keytruda for treatment of patients with unresectable or metastatic melanoma.
October 28, 2014 FDA has designated Keytruda as breakthrough therapy for treatment of patients with EGRF-negative and ALK-negative non-small cell lung cancer (NSCLC) who have progressed during or after platinum-based chemotherapy.
August 9, 2016 FDA granted accelerated approval of Keytruda in the treatment of recurrent or metastatic Head & Neck Squamous Cell Carcinoma (SCC) with disease progression on or after platinum-containing chemotherapy.
October 24, 2016 FDA approved pembrolizumab (KEYTRUDA) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.
Breakthrough therapy designation is used by the FDA to accelerate the development and evaluation of an investigational drug that is intended to treat a serious or life-threatening illness.
June 17, 2024 FDA approved pembrolizumab (Keytruda) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.
January 12, 2024 FDA approved pembrolizumab (Keytruda) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.
November 16, 2023 FDA approved pembrolizumab (Keytruda) 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.
October 31, 2023 The FDA approved pembrolizumab (Keytruda) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).
October 16, 2023 The FDA approved pembrolizumab (Keytruda) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
April 3, 2023 FDA approved Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. 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.
This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the United States for these patients.
March 31, 2023 FDA granted full approval to Keytruda for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.
January 27, 2023 FDA approved Keytruda (pembrolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for stage 1B, 2, or 3A non-small cell lung cancer.
November 12, 2021 FDA approved the anti-PD-1 therapy Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
10/13/2021 The FDA approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.
9/3/2021 Keytruda plus Lenvima have received FDA approval as first-line treatment of adult patients with advanced renal cell carcinoma. Coding note: code each agent in the appropriate treatment field: BRM for Keytruda, chemo for Lenvima.
7/9/2021 Keytruda has received an expanded label approval from FDA as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation
7/21/2021 The FDA approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
7/26/2021 The FDA approved pembrolizumab (Keytruda) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
May 5, 2021 The FDA granted accelerated approval to pembrolizumab (Keytruda) 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
March 22, 2021: FDA approved pembrolizumab (Keytruda), in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation
November 13, 2020: The FDA granted accelerated approval to pembrolizumab (KEYTRUDA) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
October 16, 2020: Keytruda (pembrolizumab) has received an expanded label use from FDA as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.
FDA also approved an updated pediatric indication for Keytruda for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy.
6/29/2020 The FDA approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy
6/24/2020 The FDA approved pembrolizumab (KEYTRUDA) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation
6/19/2020 Keytruda was approved by FDA as monotherapy 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, regardless of tumor type.
June 16, 2020: The FDA granted accelerated approval to pembrolizumab (KEYTRUDA) 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.
January 8, 2020 The FDA approved pembrolizumab (KEYTRUDA) 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.
9/20/2019 FDA has granted accelerated approval to the combination of Merck’s Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
July 30, 2019 FDA approves pembrolizumab for advanced esophageal squamous cell cancer
June 10, 2019: FDA approved pembrolizumab (KEYTRUDA) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
April 19, 2019: FDA approved pembrolizumab (KEYTRUDA) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
February 15, 2019 FDA approved pembrolizumab (KEYTRUDA, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
12/19/2018 FDA granted accelerated approval to pembrolizumab (KEYTRUDA) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
November 9, 2018: FDA granted accelerated approval to pembrolizumab (KEYTRUDA) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
October 30, 2018: FDA approved pembrolizumab (KEYTRUDA) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).
August 17, 2018: FDA approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations. .
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda®) for 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
9/29/2017: FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, 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 two or more prior lines of therapy including fluoropyrimidine-and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
6/15/2018: FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy.
5/23/217: FDA granted accelerated approval to pembrolizumab for 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 or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. May 23, 2017.
5/18/2017: FDA granted regular approval to pembrolizumab (KEYTRUDA) for 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.
5/10/2017: The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).
3/17/2017: FDA granted an accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
September 2014 FDA granted accelerated approval to pembrolizumab for treatment of patients with unresectable or metastatic melanoma and disease progression.
Update to September 2014 announcement: Final FDA approval granted to Keytruda for treatment of patients with unresectable or metastatic melanoma.
October 28, 2014 FDA has designated Keytruda as breakthrough therapy for treatment of patients with EGRF-negative and ALK-negative non-small cell lung cancer (NSCLC) who have progressed during or after platinum-based chemotherapy.
August 9, 2016 FDA granted accelerated approval of Keytruda in the treatment of recurrent or metastatic Head & Neck Squamous Cell Carcinoma (SCC) with disease progression on or after platinum-containing chemotherapy.
October 24, 2016 FDA approved pembrolizumab (KEYTRUDA) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.
Breakthrough therapy designation is used by the FDA to accelerate the development and evaluation of an investigational drug that is intended to treat a serious or life-threatening illness.
Coding
This drug should be coded
