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 (prostate cancer) as Novartis.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Radioligand Therapy
- Sub-indication
- Prostate Cancer
Related signal: Novartis initiates real-world study on Pluvicto in metastatic CRPC patients