FDAapproval65% confidence
FDA Approves First Generics of Gilotrif (afatinib) Tablets
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (lung cancer) as AstraZeneca.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: AstraZeneca's Study on MET Concordance in Treatment-Naïve NSCLC