Drug updated on 9/4/2024
Dosage Form | Injection (intravenous: 100 mg/4 mL [25 mg/mL]) |
Drug Class | 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.
- 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 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.
Latest News
Summary
- Keytruda (pembrolizumab) is indicated for the treatment of various cancers, including unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC), among others. It is used as both a single agent and in combination with other therapies, depending on the type and stage of the cancer, with specific eligibility based on tumor markers like PD-L1 expression and genomic aberrations. Keytruda is also approved for treating specific pediatric cancers and for use in combination therapies for advanced stages of several other cancers, including urothelial carcinoma, gastric cancer, and cervical cancer.
- This summary is based on the review of 92 systematic review(s)/meta-analysis(es). [1-92]
- Pembrolizumab significantly prolonged OS in patients with advanced renal cell carcinoma (RCC) post-nephrectomy and in non-small cell lung cancer (NSCLC) when combined with chemotherapy.
- Pembrolizumab plus chemotherapy significantly extended PFS in NSCLC. Additionally, in thymic carcinoma (TC), pembrolizumab achieved a median PFS of five months or greater.
- Pembrolizumab exhibited an ORR of 21% in thymic carcinoma and demonstrated higher efficiency and safety in RCC among immune checkpoint inhibitors (ICIs).
- Pembrolizumab was reported to have a relatively higher efficiency and safety profile compared to other ICIs, such as nivolumab and atezolizumab, across multiple cancer types.
- Pembrolizumab generally exhibited a favorable safety profile, with a lower incidence of grade 3-4 adverse events compared to other immune checkpoint inhibitors (ICIs).
- Combination therapies, such as pembrolizumab plus chemotherapy, were associated with a higher frequency of grade 3-4 adverse events compared to pembrolizumab monotherapy.
- Common adverse events reported with pembrolizumab included fatigue, rash, and pruritus, with severe adverse events being less frequent relative to other ICIs.
- PD-1/PD-L1 inhibitors, including pembrolizumab, were linked to an increased risk of hepatitis and pneumonitis compared to chemotherapy.
- Pembrolizumab demonstrated significant effectiveness in PD-L1 positive patients (≥50%) with NSCLC and was notably effective in intermediate-high risk RCC patients and patients with TC.
- No specific differences in safety and effectiveness were reported based on age or gender, and pembrolizumab plus chemotherapy was particularly effective in non-squamous histology of NSCLC.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Keytruda (pembrolizumab) Prescribing Information. | 2024 | Merck & Co., Whitehouse Station, NJ |