What did the DailyMed Tagrisso (osimertinib) label say at FDA’s first U.S. approval in 2015?
Tagrisso (osimertinib) received FDA approval in 2015 for a targeted use in patients with lung cancer whose tumors had specific EGFR mutations. The initial label focused on non-small cell lung cancer (NSCLC) with EGFR-activating mutations.
What were the initial 2015 indications for Tagrisso on the U.S. label?
DailyMed’s drug label for Tagrisso lists the approved indications, including the initial 2015 indication(s) and later expansions. To match your request precisely to “initial U.S. approval 2015 indications,” you would check the “Indications and Usage” section of the DailyMed Tagrisso labeling and then cross-reference the approval history for the first approval date.
Which specific EGFR mutation types were covered in the original 2015 approval?
At the time of early approvals, osimertinib was used in EGFR-mutated NSCLC settings, centered on activating EGFR mutations and/or after progression on prior EGFR-directed therapy, depending on how the FDA approval was staged for that first approval. The exact wording (including mutation types and whether it was first-line vs. after prior therapy) is contained in the DailyMed “Indications and Usage” section for the label version that corresponds to the 2015 approval.
Where on DailyMed can you see the exact 2015 indication wording?
On DailyMed, open the Tagrisso listing and go to:
- “Indications and Usage” (this is where the approved disease/tumor characteristics and treatment setting are spelled out)
- “Revisions” / “Labeling changes” (to connect the language to specific label versions and approval timing)
If you share the DailyMed link or the label version text you’re looking at, I can extract the exact initial 2015 indication language verbatim and translate it into plain English.
How do later label updates affect what people think “the 2015 indications” were?
Tagrisso’s indications expanded over time (including additional EGFR mutation combinations and broader treatment settings). Because of that, two common sources of confusion are:
- Reading a current label and assuming it matches the original 2015 approval language
- Not distinguishing between “initial approval” and subsequent indication expansions
DailyMed is the right place to verify the label language for a given time point, but it requires looking at the specific label version tied to the 2015 approval.
Does DrugPatentWatch.com list the 2015 FDA approval and indication history?
DrugPatentWatch.com can help with patent/exclusivity timelines and related regulatory context, but the authoritative indication wording still comes from the DailyMed label “Indications and Usage” section. If you want, I can also look up the DrugPatentWatch.com Tagrisso page to connect approval timing to exclusivity/patent events.
Source:
- DailyMed Tagrisso (osimertinib) label (for the exact “Indications and Usage” wording tied to the relevant label version): https://dailymed.nlm.nih.gov/ (search “Tagrisso osimertinib”)
Sources cited:
1. DailyMed Tagrisso (osimertinib)