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Keytruda + Pem/Carbo Approved for Lung Cancer
Merck news release; 2017 May 10
The FDA has had granted accelerated approval to Keytruda (pembrolizumab) in combination with pemetrexed and carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.
Indications: Keytruda is a programmed death receptor-1-blocking antibody indicated for the treatment of NSCLC in combination with pemetrexed and carboplatin, as first-line treatment of patients with metastatic nonsquamous NSCLC.
Dosage and administration: 200 mg every 3 weeks.
Efficacy and safety: Approval is based on data from KEYNOTE-021, where Keytruda + pem/carbo demonstrated superior objective response, duration of response, and progression free survival vs pem/carbo alone.
Side effects/risks: The most common adverse reactions are fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea.
FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. [news release]. Kenilworth, NJ: Merck & Co, Inc. May 10, 2017. http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-first-line-combin. Accessed May 14, 2017.
Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co, Inc. 2017. http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Accessed May 14, 2017.