Spectrum’s Zevalin Still Living In Rituxan’s Shadow, FDA Advertising Letter Shows
This article was originally published in The Pink Sheet Daily
FDA citations of Rituxan comparisons in a promotion for Zevalin throw added salt on old wounds for drug that has taken backseat to Rituxan’s blockbuster story.
You may also be interested in...
FDA advertising enforcement does not preference black-box drugs despite risk-based approach prioritizing products with significant risks; nor are drugs with small patient populations exempt from risk-based approach.
The small oncology company may be able to succeed with the non-Hodgkin lymphoma drug where others have failed.
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.