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FDA Approves Keytruda for NSCLC
FDA news release; 2016 Oct 24
The FDA has approved Keytruda (pembrolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).
Indications: Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with metastatic NSCLC whose tumors:
- have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC; or
- express PD-L1 with disease progression on or after platinum-containing chemotherapy.
Dosage and administration: 200 mg every 3 weeks, as an IV infusion over 30 minutes.
Efficacy and safety: Approval is based on results of 2 trials that demonstrated statistically significant improvements in progression-free and overall survival for patients randomized to pembrolizumab.
Side effects/risks: Most common adverse reactions are fatigue, pruritus, diarrhea, decreased appetite, rash, dyspnea, constipation, and nausea.
Pembrolizumab (Keytruda) Checkpoint Inhibitor [news release]. Silver Spring, MD: FDA October 24, 2016. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm526430.htm. Accessed October 26, 2016.
Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf. Accessed October 26, 2016.