FDA records dated 14 September show a supplement to AstraZeneca's new drug application for osimertinib (Tagrisso, NDA208065). The record does not say what the supplement covers: supplements can be new indications, labelling changes or manufacturing updates, and this entry gives no detail.
Until the updated label or an FDA announcement is published, there is no change for prescribers. Osimertinib remains a standard option for EGFR-mutated non-small-cell lung cancer, and is available in India.
- No change to prescribing until the content of the supplement is published
- Watch for an updated label on the FDA database
- Continue current EGFR testing and treatment pathways
Why it matters
A supplement can signal a label change, so it is worth watching, but it is not yet news.
Don't overread it
A licence supplement is not a new indication until the label says so.
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