FDAsafety guidance66% 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 (colorectal cancer) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
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 · Immunotherapy
- Sub-indication
- Colorectal Cancer
Related signal: FDA grants Priority Review for Roche’s Tecentriq in stage III colon cancer