FDAsafety guidance72% confidence
Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (prostate cancer) as Novartis.
Regulatory Analysis
FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
Supporting Context
- Therapeutic area
- Oncology · Imaging
- Sub-indication
- Prostate Cancer
Related signal: First-in-human study of NTSR1-targeted imaging in prostate cancer shows promise