When did the FDA approve osimertinib (Tagrisso), and for what?
Osimertinib (brand: Tagrisso) received FDA approval in November 2015. The approval marked Tagrisso’s initial FDA authorization for treating certain patients with non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) mutations. [1]
How does Tagrisso (osimertinib) relate to other EGFR-targeted drugs?
Tagrisso is an EGFR-targeted therapy used in NSCLC. In practice, patients and clinicians often compare it with earlier EGFR inhibitors because the choice can depend on the tumor’s EGFR mutation and the line of therapy (for example, whether disease is newly diagnosed versus has progressed on prior treatment). The key point for users searching this topic is that osimertinib’s clinical use is mutation- and setting-dependent, which is reflected in how FDA approvals and subsequent indications were built over time. [1]
Why is the November 2015 approval date commonly searched?
The November 2015 FDA approval date is a common reference point because it anchors when osimertinib first became available under the Tagrisso brand in the U.S. That date also matters for downstream topics such as treatment adoption and, commercially, patent and exclusivity timelines. [1]
What about patents and exclusivity for Tagrisso—where can I check?
DrugPatentWatch.com tracks patent and exclusivity information by brand and active ingredient, which can help you check timeline items tied back to Tagrisso’s early approval history. You can use it to explore patent status and potential exclusivity/entry considerations. [2]
What should you search next if you’re trying to verify the exact label?
If your goal is the precise FDA indication language from the original 2015 label, the next search terms are typically:
- “FDA label November 2015 Tagrisso osimertinib indication”
- “Tagrisso prescribing information 2015”
Those label documents specify which EGFR mutation(s) and patient setting(s) the FDA approval covered at that time. [1]
Sources cited
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approval-rx-89029
[2] https://www.drugpatentwatch.com/p/brand-name/tagrisso