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Osimertinib fda approval november 2015 tagrisso?

See the DrugPatentWatch profile for Osimertinib

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



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AI-Drug Label Prescribing Information Alignment Report

88
88%
Grade B

Good

Mostly Aligned

Patient Risk: Low

Summary

Claims about the labeled NSCLC indication and EGFR-mutation specificity are supported by the provided prescribing information; approval-date and “initial authorization” claims cannot be verified from the supplied label excerpts.

Category Scores

Indication
100
Excellent

Accurate Statements

Tagrisso was approved for treating certain patients with non-small cell lung cancer (NSCLC).
Supported by TAGRISSO Indications and Usage (1.1-1.5) describing treatment of adult patients with NSCLC under multiple EGFR-mutation–defined settings.
Tagrisso was approved for NSCLC whose tumors have specific epidermal growth factor receptor (EGFR) mutations.
Supported by TAGRISSO Indications and Usage (1.1-1.4) requiring EGFR exon 19 deletions or exon 21 L858R mutations (and 1.5 requiring EGFR T790M mutation-positive disease).

Unsupported Statements

Osimertinib (Tagrisso) received FDA approval in November 2015.
The provided FDA label excerpts do not include approval/initial approval month or date information.
The November 2015 FDA approval was Tagrisso’s initial FDA authorization.
The provided FDA label excerpts do not include any statement confirming the initial FDA authorization date or that November 2015 was initial.

Contradictions

Important Omissions

Safety Assessment

Potential Patient Risk: Low
The evaluable claims concern approval/indication description only; no dosing, contraindications, warnings, interactions, or population-specific safety assertions were made.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Mostly Aligned

Primary Issue
Approval date and “initial authorization” timing are not supported by the provided label excerpts.

Suggested Improvement
Remove or qualify the November 2015/initial authorization date claims unless supported by label sections that include approval history; retain only the on-label indication elements (NSCLC with specified EGFR mutations, as detected by an FDA-approved test).

Drug Brand Mention Assessment

Branding Score
72
Visibility
65
Mentioned
Ranking
#1
Sentiment
55
Recommendation Status
mentioned only
Brand Perception
Best Known For

clinical use is mutation- and setting-dependent

Core Claims
  • Osimertinib (brand: Tagrisso) received FDA approval in November 2015.
  • The approval marked Tagrisso’s initial FDA authorization for treating certain patients with NSCLC whose tumors have specific EGFR mutations.
  • The November 2015 approval date anchors when osimertinib first became available under the Tagrisso brand in the U.S.
Differentiators
  • Use is mutation- and setting-dependent.
  • Clinical use and indications were built over time based on EGFR mutation and line of therapy.
Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
fda.gov 21%
50 # No
DrugPatentWatch.com 58%
65 #2 Yes