KEYTRUDA NOW APPROVED FOR METASTATIC SQUAMOUS AND NONSQUAMOUS NSCLC (Merck)
KEYTRUDA is indicated for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express 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 KEYTRUDA. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Please Note the Following:
INDICATIONS AND USAGE:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of:
- patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. (1.1)
- patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test and who have 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. (1.2)
These indications are approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
- Administer 2 mg/kg as an intravenous infusion over 30 minutes every 3 weeks. (2.2)
- Dilute prior to intravenous infusion. (2.4)
DOSAGE FORMS AND STRENGTHS
- For injection: 50 mg lyophilized powder in single-use vial for reconstitution (3)
- Injection: 100 mg/4 mL (25 mg/mL) solution in a single-use vial (3)
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