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FDA approval for Keytruda (pembrolizumab) in lung cancer began in 2015. The FDA approved it for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors had high PD-L1 expression, making it one of the earliest lung-cancer indications for the drug.[1]
Yes. After the initial 2015 NSCLC approval, the FDA added additional lung-cancer indications over time (including other NSCLC settings and combinations), reflecting new clinical evidence and eligibility criteria.[1]
“Lung cancer use” can refer to different FDA-labeled settings, such as metastatic NSCLC with PD-L1 testing, combination therapy, or treatment of earlier-stage disease. If you tell me whether you mean non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC), and whether it’s metastatic or early-stage, I can narrow the approval date to the specific label. Sources: [1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514
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