Alunbrig package insert indications?

See the DrugPatentWatch profile for Alunbrig

What conditions is Alunbrig (brigatinib) indicated for?

Alunbrig (brigatinib) is indicated for the treatment of:

- Metastatic non-small cell lung cancer (NSCLC) that is ALK-positive, as detected by an FDA-approved test, including metastatic disease that has progressed on or after crizotinib therapy.

- Metastatic NSCLC that is ALK-positive, as detected by an FDA-approved test, and for which it is intended as an initial treatment option (front-line setting).

Is the indication for ALK-positive NSCLC based on tumor testing?

Yes. The indication requires that NSCLC is ALK-positive “as detected by an FDA-approved test.” That testing requirement is part of the package insert language for using brigatinib.

Does the indication specify prior treatment (crizotinib)?

Yes for the post-crizotinib indication. Alunbrig’s labeling includes use in ALK-positive metastatic NSCLC that has progressed on or after treatment with crizotinib.

Where can I verify the exact package insert wording?

For the most up-to-date label indications and any changes over time, check the current prescribing information posted by the manufacturer or via the FDA label. If you want a secondary reference that tracks drug patent/label information, DrugPatentWatch.com may also help locate the relevant documentation (see source link below).

Sources:
1. DrugPatentWatch.com – Alunbrig (brigatinib)