Drug updated on 12/11/2024
Dosage Form | Injection (intravenous: 100 mg/4 mL [25 mg/mL]) |
Drug Class | Human programmed death receptor-1 (PD-1) blocking antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with unresectable or metastatic melanoma
- Indicated 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 nonsquamous 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
- Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA
- Indicated for the treatment of patients with resectable (tumors 4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
- Indicated as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a 4 cm), II, or IIIA NSCLC
- Indiacted in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic Malignant Pleural Mesothelioma (MPM)
- 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
- Indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL)
- Indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy
- Indicated for the treatment of adult and pediatric patients with refractory primary eediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy
- Indicated in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer
- Indicated as a single agent 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
- Indicated as a single agent 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
- Indicated 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
- Indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test
- 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 whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test
- Indicated in combination 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
- Indicated 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 chemoradiotherapy, for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer
- 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
- Indicated for the treatment of patients with Hepatocellular Carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD1/PD-L1-containing regimen
- Indicated in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer
- Indicated 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
- Indicated 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 carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma
- Indicated in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDAapproved test or not MSI-H, 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 adult 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
- Indicated 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
- Indicated for the treatment of patients with recurrent or metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation
- Indicated for the treatment of patients with 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
- 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
- Indicated for adult Classical Hodgkin Lymphoma and Adult Primary Mediastinal Large B-Cell Lymphoma (for use at an additional recommended dosage of 400 mg every 6 weeks for Classical Hodgkin Lymphoma and Primary Mediastinal Large B-Cell Lymphoma in adults).
Latest News
Summary
- This summary is based on the review of 193 systematic review(s)/meta-analysis(es). [1-193]
- In hepatocellular carcinoma (HCC), hepatic artery infusion chemotherapy with oxaliplatin and fluorouracil (HAIC-FO) showed the highest overall survival (OS) and objective response rate (ORR) among treatments, while pembrolizumab plus lenvatinib improved progression-free survival (PFS) but was not superior to combinations such as lenvatinib with transcatheter arterial chemoembolization (TACE).
- In advanced urothelial carcinoma (aUC), the combination of pembrolizumab and enfortumab vedotin (PEM+EV) demonstrated superior OS, PFS, and ORR compared to treatments like nivolumab or atezolizumab with platinum-based chemotherapy and platinum-based chemotherapy alone.
- For renal cell carcinoma (RCC), pembrolizumab significantly improved disease-free survival (DFS) and OS in patients with high-risk clear cell RCC and resected metastatic disease (M1 NED), while lenvatinib with pembrolizumab showed a numerical improvement in OS without statistical significance in intermediate-/poor-risk patients compared to other therapies.
- In breast cancer (HR+/HER2-), the combination of pembrolizumab and chemotherapy led to a significantly higher pathological complete response (pCR) compared to chemotherapy alone, showing its potential efficacy in this patient group.
- In HCC, pembrolizumab treatment was associated with grade 3 or higher adverse events, though specific details on these adverse events were not provided.
- For aUC, pembrolizumab combined with enfortumab vedotin showed a significantly lower incidence of severe (grade 3 or higher) adverse events compared to nivolumab and platinum-based chemotherapy.
- In RCC, pembrolizumab in combination with lenvatinib had a higher frequency of adverse events, yet the toxicities were considered manageable within the study’s scope.
- In breast cancer, the combination of pembrolizumab and chemotherapy presented a higher incidence of adverse effects, particularly hematological toxicity, gastrointestinal reactions, and neuropathy, compared to chemotherapy alone.
- In HCC, patients with macrovascular invasion (MVI) and extrahepatic spread (EHS) showed significant survival benefits with HAIC-FO therapy, while pembrolizumab combined with durvalumab demonstrated positive outcomes specifically in Asian populations.
- For RCC, pembrolizumab showed enhanced benefits in high-risk groups, including patients with resected metastatic disease (M1 NED), and for non-small cell lung cancer (NSCLC), pembrolizumab combined with chemotherapy improved outcomes across PD-L1 expression levels and histology types, providing particular benefit in patients with high PD-L1 expression.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Keytruda (pembrolizumab) Prescribing Information. | 2024 | Merck & Co., Whitehouse Station, NJ |