Melanoma (adjuvant and unresectable/metastatic); Non-small cell lung cancer (NSCLC) — first-line monotherapy (PD-L1 TPS ≥1%), first-line combination with chemo, after progression on platinum chemo; Small cell lung cancer; Head and neck squamous cell carcinoma; Classical Hodgkin lymphoma; Primary mediastinal large B-cell lymphoma; Urothelial carcinoma; Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors; Gastric/GEJ adenocarcinoma; Esophageal cancer; Cervical cancer; Hepatocellular carcinoma; Merkel cell carcinoma; Renal cell carcinoma; Endometrial carcinoma; Tumor mutational burden-high (TMB-H) solid tumors; Cutaneous squamous cell carcinoma; Triple-negative breast cancer; Biliary tract cancer
Adults: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Pediatric (MSI-H/dMMR): 2 mg/kg (up to 200 mg) IV every 3 weeks.
Infusion time: Administer over 30 minutes.
Injection: 25 mg/mL solution in 4 mL single-dose vial (100 mg); Lyophilized powder: 50 mg in single-dose vial for reconstitution
No absolute contraindications are listed in the prescribing information. Use is contraindicated in patients with known severe hypersensitivity to pembrolizumab or any component of the formulation.
Fatigue (34%), musculoskeletal pain (22%), rash (22%), diarrhea (22%), pruritus (20%), decreased appetite (16%), nausea (16%), cough (15%), pyrexia (13%), constipation (12%), hypothyroidism (12%)
Immune-mediated pneumonitis (3.4%), immune-mediated colitis (2.3%), immune-mediated hepatitis (1.3%), immune-mediated nephritis (0.7%), severe skin reactions (1.7%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. Systemic corticosteroids or immunosuppressants should be avoided before starting pembrolizumab due to potential interference with pharmacodynamic activity.
Category D equivalent — Can cause fetal harm. Verify pregnancy status prior to initiation. Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.
Safety and effectiveness established for MSI-H/dMMR cancers in pediatric patients. Not established for other indications in patients <18 years.
No dose adjustment recommended for mild or moderate renal impairment. Not studied in severe renal impairment. No dose adjustment for mild hepatic impairment (bilirubin ≤ULN with AST >ULN, or bilirubin >1 to 1.5× ULN). Not studied in moderate or severe hepatic impairment.
Pembrolizumab is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor on T cells, blocking its interaction with ligands PD-L1 and PD-L2. This releases PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, thereby restoring T-cell-mediated killing of tumor cells.
Steady-state concentration reached by 16 weeks with repeated dosing every 3 weeks. Terminal half-life: approximately 22 days. Volume of distribution: 6.0 L. Clearance: 0.22 L/day.
Clinical efficacy and safety data supporting the approval of Keytruda are available in the full prescribing information and from the clinical trials listed below.
Keytruda has FDA-approved indications across the following cancer types covered on PipelineEvidence: