Cell Therapy News/Articles, page-6249

Comparing the ODAC vote on Redectane to Remesetmcel-L, and a subsequent FDA decision, is not completely logical or relevant.

The safety of Redectane was questioned by the FDA (Remestemcel's safety profile is entirely unquestioned), and the outcomes of Redectane - such as patient survival following detection and treatment/removal of cancer - had yet to assessed in a robust trial. Patient outcomes associated with Remestemcel use has been assessed; I expect a phase IV trial may still be requested by the FDA, which MSB has already stated they are prepared to conduct, assessing Remestemcel against the competition in adults with SR-aGVHD.

ODAC voted that Redectane was 'useful' in detecting cancer; vastly different to ODAC voting that Remestemcel is efficacious in improving survival of paediatric SR-aGHVD patients (for which there is no other treatment available).

8 years also have passed since these two therapies were voted on. Processes, procedures and (government and public) expectations can, and have, changed significantly in this time. You only need to observe the current political environment to understand there are differences.


TLDR: Your comparison between these two therapies is lacking some logic.