Free Research Preview. DrugChatter may produce inaccurate information.
Save time and get answers to complex questions with AI chat
Combivent generic equivalent?Patent tenofovir alafenamide gilead?How does insurance coverage impact nivolumab's duration?When will generic fiasap insulin be available?When will there be a generic loreev available?
See the DrugPatentWatch profile for keytruda
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
Other Questions About Keytruda :