Pembrolizumab (Keytruda)

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General information

Class/mechanism: PD-1 antibody. Pembrolizumab is a humanized monoclonal antibody which binds to the PD-1 receptor on T-cells. In some cancers, the PD-1 ligands are upregulated, which results in inhibition of T-cell immune surveillance of tumors. By blocking the interaction between the PD-1 receptor and its ligands PD-L1 and PD-L2, pembrolizumab decreases this immune system inhibition and facilitates anti-tumor immune response.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Toxicity management

Diseases for which it is established

Diseases for which it is used

Diseases for which it was used

Patient drug information

Management checklist

  • CBC, comprehensive metabolic panel, Mg, Phos, LDH, TSH. Consider baseline EKG and troponin.

History of changes in FDA dosing recommendations

History of changes in FDA indication

Biliary tract cancer

  • 2023-10-31: Approved in combination with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). (Based on KEYNOTE-966)

Bladder cancer

  • 2020-01-08: Approved 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. (Based on KEYNOTE-057)

Cervical cancer

  • 2018-06-12: Accelerated approval for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS at least 1) as determined by an FDA-approved test. (New disease indication; based on KEYNOTE-158cervical)
    • 2021-10-13: Full approval in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS at least 1) (Based on KEYNOTE-826)
  • 2024-01-12: Approved with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer. (Based on KEYNOTE-A18)

Classical Hodgkin lymphoma (cHL)

  • 2017-03-14: Accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL). (New disease indication; based on KEYNOTE-087)
    • 2020-04-30: Converted to regular approval. (No supporting studies are cited)
  • 2017-03-14: Accelerated approval for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) that has relapsed after three or more prior lines of therapy. (New disease indication; based on KEYNOTE-087)
    • 2020-04-30: Converted to regular approval. (No supporting studies are cited)
  • 2020-10-15: Approved for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). (Prior treatment criteria relaxed; based on KEYNOTE-204)
  • 2020-10-15: Approved for the treatment of pediatric patients with refractory classical Hodgkin lymphoma (cHL). (Prior treatment criteria relaxed; based on KEYNOTE-204)
  • 2020-10-15: Approved for the treatment of pediatric patients with classical Hodgkin lymphoma (cHL) that has relapsed after 2 or more lines of therapy. (Approval extended to third-line pediatric setting; based on KEYNOTE-204)

Colorectal cancer, MSI-H or dMMR

Cutaneous squamous cell carcinoma

Endometrial cancer

  • 2019-09-17: Accelerated approval in combination with Lenvatinib (Lenvima) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. (New disease indication; based on KEYNOTE-146)
    • 2021-07-21: Full approval 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. (Based on KEYNOTE-775)
  • 2022-03-21: Approved as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. (Based on KEYNOTE-158endometrial)

Esophageal cancer

  • 2021-03-22: Approved 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. (Histology-specific restriction removed; protein expression requirement removed; prior therapy requirement removed; surgery and radiation eligibility restriction added; drug combination requirement added; based on KEYNOTE-590)

Esophageal squamous cell carcinoma

  • 2019-07-30: Approved for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] at least 10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. (New disease indication; based on KEYNOTE-180 and KEYNOTE-181)

Gastric or gastroesophageal junction adenocarcinoma - PARTIALLY WITHDRAWN

  • 2017-09-22: Accelerated approval for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy. (New disease indication; based on KEYNOTE-059)
    • 2022-02-04: Accelerated approval for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy withdrawn by manufacturer.
  • 2021-05-05: Granted accelerated approval 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. (Based on KEYNOTE-811)
    • 2023-11-07: Accelerated approval revised 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 with tumors that express PD-L1 (CPS at least 1). (New biomarker restriction; based on KEYNOTE-811)
  • 2023-11-16: Approved 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. (Based on KEYNOTE-859)

Head and neck squamous cell carcinoma

  • 2016-08-05: Accelerated approval for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. (New disease indication; based on KEYNOTE-012)
  • 2019-06-10: Converted to regular approval and approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) for all patients. (Approval extended to first-line setting; based on KEYNOTE-048)
  • 2019-06-10: Converted to regular approval and approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as a single agent for patients whose tumors express PD-L1 (Combined Positive Score [CPS] at least 1) (Approval extended to first-line setting; based on KEYNOTE-048)

Hepatocellular carcinoma

Melanoma

  • 2014-09-04: Initial accelerated approval for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab, and if BRAF V600 mutation positive, a BRAF inhibitor. (Based on KEYNOTE-002)
    • 2015-12-18: Converted to regular approval for the treatment of patients with unresectable or metastatic melanoma. (Converted to regular approval; requirement for progression removed; based on KEYNOTE-006)
  • 2019-02-15: Approved for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. (Indication expanded to adjuvant setting; based on KEYNOTE-054)
  • 2021-12-03: Approved for the adjuvant treatment of adult and pediatric (12 years of age or older) patients with stage IIB or IIC melanoma following complete resection. (Based on KEYNOTE-716)

Merkel cell carcinoma

MSI-H or dMMR tumors (tissue-agnostic)

Non-small cell lung cancer

  • 2015-10-02: Accelerated approval for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) 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 pembrolizumab. (New disease indication; based on KEYNOTE-010)
  • 2016-10-24: Full approval for patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC. (First-line indication with biomarker requirement; based on KEYNOTE-024)
  • 2016-10-24: Full approval for patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 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 pembrolizumab. (Indication with biomarker requirement; based on KEYNOTE-042)
  • 2019-04-11: Approval expanded for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] greater than or equal to 1%) (Approval expanded to the non-metastatic setting; based on KEYNOTE-042)
  • 2023-01-26: Approved for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a at least 4 cm), II, or IIIA non-small cell lung cancer (NSCLC). (Approval expanded to the maintenance setting; Based on PEARLS)
  • 2023-10-16: Approved 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). (Based on KEYNOTE-671)

Non-small cell lung cancer, nonsquamous

Non-small cell lung cancer, squamous

  • 2018-10-30: Approval expanded in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). (First-line indication with histology requirement; based on KEYNOTE-407)

Primary mediastinal B-cell lymphoma

  • 2018-06-13: Accelerated approval for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL). (New disease indication; based on KEYNOTE-170)
  • 2018-06-13: Accelerated approval for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed after two or more prior lines of therapy. (New disease indication; based on KEYNOTE-170)
  • 2020-10-14: Converted to regular approval. (No supporting studies are cited)

Renal cell carcinoma

Small cell lung cancer - WITHDRAWN

TMB-H (tissue agnostic)

  • 2020-06-16: Accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [at least 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. (New disease-agnostic indication; based on KEYNOTE-158TMB-H)

Triple-negative breast cancer (TNBC)

  • 2020-11-13: Accelerated approval 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 at least 10) as determined by an FDA approved test. (New disease indication; based on KEYNOTE-355)
  • 2021-07-26: Regular approval 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. (Based on KEYNOTE-522)
  • 2021-07-26: Regular approval in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] at least 10) as determined by an FDA approved test. (Based on KEYNOTE-522)

Urothelial carcinoma

History of changes in EMA indication

Biliary cancer

  • 2022-04-25: Extension of indication for KEYTRUDA as monotherapy in adults with unresectable or metastatic MSI-H or dMMR biliary cancer, who have disease progression on or following at least one prior therapy. (Based on KEYNOTE-158)
  • 2023-11-09: CHMP recommendation - KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.

Breast cancer, triple negative

  • 2021-10-19: Extension of indication for Keytruda to include in combination with chemotherapy, treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD L1 with a CPS of at least 10 and who have not received prior chemotherapy for metastatic disease.
  • 2022-05-19: Extension of indication for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery of adults with locally advanced breast cancer.
  • 2022-05-19: Extension of indication for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery of adults with early-stage triple-negative breast cancer at high-risk of recurrence.

Cervical cancer

  • 2022-04-25: Extension of indication to include a new indication for Keytruda, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults.

Classical Hodgkin lymphoma

  • 2017-05-02: Extension of indication to include monotherapy treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV). (Based on KEYNOTE-087)
  • 2017-05-02: Extension of indication to include monotherapy treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who are transplant-ineligible and have failed BV. (Based on KEYNOTE-087)
  • 2021-03-09: Extension of indication as follows: KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

Colorectal cancer, MSI-H or dMMR

  • 2021-01-21: Extension of indication to include first-line treatment of metastatic microsatellite instability-high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults. (Based on KEYNOTE-177)
  • 2022-04-25: Extension of indication for KEYTRUDA as monotherapy in adults with unresectable or metastatic MSI-H or dMMR colorectal cancer after previous fluoropyrimidine-based combination therapy. (Based on KEYNOTE-164)

Endometrial cancer

  • 2021-11-15: Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.
  • 2022-04-25: Extension of indication for KEYTRUDA as monotherapy in adults with advanced or recurrent MSI-H or dMMR endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. (Based on KEYNOTE-158endometrial)

Esophageal cancer

  • 2021-06-24: Extension of indication to include in combination with platinum and fluoropyrimidine-based chemotherapy, first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS of at least 10. (Based on KEYNOTE-590)
  • 2023-10-12: CHMP approved revised indication to include in combination with platinum and fluoropyrimidine-based chemotherapy, first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD L1 with a CPS of at least 10.

Gastric cancer

  • 2022-04-25: Extension of indication for KEYTRUDA as monotherapy in adults with unresectable or metastatic MSI-H or dMMR gastric cancer, who have disease progression on or following at least one prior therapy. (Based on KEYNOTE-158)
  • 2023-08-23: Extension of indication to include in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma for Keytruda. (Based on KEYNOTE-811)
  • 2023-10-12: CHMP adopted new indication Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS at least 1

Head and neck cancer

  • 2018-09-04: Extension of Indication to include treatment as monotherapy of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with at least 50% TPS and progressing on or after platinum-containing chemotherapy. (Based on KEYNOTE-040)
  • 2019-11-14: Extension of indication to include, as monotherapy or in combination with platinum and 5-fluorouracil (5FU) chemotherapy, the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose disease expresses PD-L1 with CPS score at least 1. (Based on KEYNOTE-048)

Melanoma

  • 2015-07-17: Initial marketing authorization as Keytruda. Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. (Based on KEYNOTE-001melanoma)
  • 2018-12-12: Extension of Indication to include (as monotherapy) adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection. (Based on KEYNOTE-054)
  • 2023-06-22: Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, Stage IIC or stage III melanoma.
  • 2023-06-22: Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with advanced melanoma.

Non-small cell lung cancer

  • 2016-07-29: Extension of Indication to include a new indication for Keytruda in second line Non-Small Cell Lung Cancer (NSCLC).
  • 2017-01-27: Extension of Indication to include first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with at least 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
  • Future date (positive CHMP summary of opinion): Extension of indication for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy.

Non-small cell lung cancer, nonsquamous

  • 2018-09-04: Extension of Indication to include 1st line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations, in combination with pemetrexed and platinum chemotherapy. (Based on KEYNOTE-189)

Non-small cell lung cancer, squamous

  • 2019-03-11: Extension of indication to include, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous NSCLC in adults.

Renal cell carcinoma

  • 2019-08-26: Extension of Indication to include first line treatment of advanced or metastatic renal cell carcinoma (RCC) as combination therapy of pembrolizumab together with axitinib. (Based on KEYNOTE-426)
  • 2021-11-15: Extension of indication to include Keytruda in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC).
  • 2022-01-24: Extension of indication to include the adjuvant treatment in monotherapy of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Small bowel adenocarcinoma

  • 2022-04-25: Extension of indication for KEYTRUDA as monotherapy in adults with unresectable or metastatic MSI-H or dMMR small intestine cancer, who have disease progression on or following at least one prior therapy. (Based on KEYNOTE-158)

Urothelial carcinoma

  • 2017-08-24: Extension of indication for KEYTRUDA as monotherapy of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. (Based on KEYNOTE-045)
  • 2017-08-24: Extension of Indication to add treatment as monotherapy of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy. (Based on KEYNOTE-052)
  • 2018-07-06: Restriction of indication in cisplatin-ineligible urothelial carcinoma patients to exclude patients whose tumours express PD-L1 with a combined positive score (CPS) less than 10. (Based on KEYNOTE-361)

History of changes in Health Canada indication

Classical Hodgkin lymphoma

  • 2021-02-03: Indication as a monotherapy, for the treatment for adult patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) or who are not ASCT candidates and have failed BV withdrawn.
  • 2021-02-05: Notice of compliance with conditions for the treatment of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT).
  • 2021-02-05: Notice of compliance with conditions for the treatment of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who are not candidates for multi-agent salvage chemotherapy and ASCT.

Colorectal cancer

  • 2019-04-18: Notice of compliance with conditions for the treatment of adults with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Endometrial cancer

  • 2019-04-18: Notice of compliance with conditions for the treatment of adults with MSI-H or dMMR endometrial cancer that has progressed following prior therapy and who have no satisfactory alternative treatment options.
  • 2019-09-20: Notice of compliance with conditions for the treatment of adults patients, in combination with lenvatinib, with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy and are not candidates for curative surgery or radiation.

Primary mediastinal B-cell lymphoma

Urothelial carcinoma

  • 2019-04-11: Notice of compliance with conditions for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy, in adults who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) at least 10] as determined by a validated test.
  • 2019-04-11: Notice of compliance with conditions for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy, in adults who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

History of changes in PMDA indication

Breast cancer

  • 2021-08-25: New indication and a new dosage for the treatment of PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer.
  • 2022-09-26: New indication and a new dosage for the preoperative and postoperative adjuvant treatment of hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)negative breast cancer with a high risk of recurrence.

Cervical cancer

  • 2022-09-26: New indication for the treatment of advanced or recurrent cervical cancer.

Classical Hodgkin lymphoma

Colorectal cancer

  • 2021-08-25: New indication for the treatment of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer.

Endometrial cancer

  • 2021-12-24: New indication and a new dosage for the treatment of unresectable advanced or recurrent endometrial carcinoma that has progressed after cancer chemotherapy.

Esophageal cancer

  • 2020-08-21: New indication and a new dosage for the treatment of unresectable advanced or recurrent PD-L1-positive esophageal squamous cell carcinoma that has progressed after cancer chemotherapy.
  • 2021-11-25: New indication and a new dosage for the treatment of unresectable advanced or recurrent esophageal cancer.

Head and neck cancer

Melanoma

  • 2016-09-28: New approval for the treatment of unresectable melanoma.
  • 2018-12-21: New indication for melanoma.

MSI-H or dMMR tumors (tissue-agnostic)

  • 2018-12-21: Conditional new indication for advanced or recurrent microsatellite instability-high (MSI-High) solid tumors that have progressed after cancer chemotherapy (for use only if refractory or intolerant to standard therapies)

Non-small cell lung cancer

  • 2016-12-19: New additional indication and a new dosage for the treatment of patients with PD-L1-positive, unresectable, recurrent or advanced non-small cell lung cancer.
  • 2018-12-21: New indication for unresectable advanced or recurrent non-small cell lung cancer.

Renal cell carcinoma

  • 2019-12-20: New indication and a new dosage for the treatment of unresectable or metastatic renal cell carcinoma.
  • 2022-08-24: New indication and a new dosage for postoperative adjuvant treatment for renal cell carcinoma.

TMB-H (tissue agnostic)

  • 2022-02-25: New indication for the treatment of advanced or recurrent solid tumors with tumor mutation burden-high (TMB-high) that have progressed after cancer chemotherapy (for use only if refractory or intolerant to standard therapies).

Urothelial carcinoma

  • 2017-12-25: New additional indication for the treatment of unresectable urothelial cancer which progressed after cancer chemotherapy.

Also known as

  • Code names: MK-3475, SCH-900475
  • Generic names: lambrolizumab
  • Brand name: Keytruda

References

  1. ↑ 1.0 1.1 1.2 Pembrolizumab (Keytruda) package insert
  2. ↑ Pembrolizumab (Keytruda) package insert (locally hosted backup)
  3. ↑ Keytruda manufacturer's website
  4. ↑ Pembrolizumab (Keytruda) patient drug information (Chemocare)
  5. ↑ Keytruda wallet card about side effects
  6. ↑ Pembrolizumab (Keytruda) patient drug information (UpToDate)
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