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When did keytruda receive fda approval for lung cancer use?

See the DrugPatentWatch profile for keytruda

When did Keytruda first get FDA approval for lung cancer?

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]

Did Keytruda’s lung-cancer approvals expand after that first approval?

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]

Which exact lung-cancer type and setting are you asking about?

“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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