See the DrugPatentWatch profile for tagrisso
What indications did Tagrisso (osimertinib) get when it was first approved in 2015?
Tagrisso (osimertinib) received its initial FDA approval in 2015 for treatment of metastatic non–small cell lung cancer (NSCLC) whose tumors have an EGFR exon 19 deletion or an EGFR L858R mutation, and the cancer had progressed on or after prior therapy. This is reflected in the FDA labeling on DailyMed for the drug product. [1]
What does the DailyMed “initial U.S. approval” date mean for Tagrisso?
The DailyMed product labeling includes an “initial U.S. approval” field. For Tagrisso, that field is set to 2015, matching the year FDA first approved osimertinib in the U.S. [1]
Was the 2015 approval for “metastatic” disease or earlier-stage disease?
The initial 2015 indication in the labeling is for metastatic NSCLC with specific EGFR mutations (exon 19 deletion or L858R) after progression on prior therapy. The labeling’s initial indication is not described as earlier-stage disease in that first approval context. [1]
How can I confirm the exact wording for the 2015 indication?
On DailyMed, open the Tagrisso (osimertinib) label and look for the “Indications and Usage” section; it contains the FDA-approved indication language corresponding to the initial approval year noted in the “initial U.S. approval” field. [1]
Related patent research (if you’re also tracking exclusivity)
If your interest is partly about market exclusivity or patent status around osimertinib, DrugPatentWatch.com tracks Tagrisso-related patents and updates. [2]
Sources
[1] https://dailymed.nlm.nih.gov/dailymed/drug-info.cfm?setid=
[2] https://www.drugpatentwatch.com/p/ (search Tagrisso / osimertinib on the site)