Drug updated on 7/25/2024
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.
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Summary
- Pembrolizumab (Keytruda) is indicated for the treatment of various cancers, including unresectable or metastatic melanoma and non-small cell lung cancer (NSCLC).
- The total number of reviewed studies is 92, derived from systematic reviews and meta-analyses.
- In patients with advanced melanoma, pembrolizumab shows better survival rates compared to other immune checkpoint inhibitors when used alone or in combination with chemotherapy.
- For NSCLC patients without EGFR or ALK genomic tumor aberrations, pembrolizumab combined with platinum-based chemotherapy improves overall survival significantly more than standard treatments.
- Pembrolizumab demonstrates a manageable safety profile across different indications; common adverse events include hypothyroidism and hyperthyroidism.
- In head and neck squamous cell carcinoma (HNSCC), pembrolizumab plus chemotherapy yields higher overall survival for PD-L1 positive patients compared to standard chemotherapy alone.
- Among renal cell carcinoma (RCC) patients, combining pembrolizumab with axitinib results in superior overall survival outcomes versus sunitinib monotherapy.
- For triple-negative breast cancer (TNBC), especially PD-L1 positive cases, the combination of pembrolizumab and chemotherapy enhances both progression-free survival and overall survival metrics over traditional therapies.
- Pediatric populations benefit from pembrolizumab in treating refractory classical Hodgkin lymphoma after multiple lines of therapy have failed.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Keytruda (pembrolizumab) Prescribing Information. | 2024 | Merck & Co., Whitehouse Station, NJ |