On Tuesday, March 20, 2012, the FDA Oncology Drug Advisory Committee will discuss the Merck and Ariad‘s application for TALTORIC (ridaforolimus) in the treatment of metastatic soft tissue sarcoma and bone sarcoma.
This has to be one of the shortest Briefing Documents ever prepared by the FDA for an Advisory Committee Meeting, and rightly so. There are just not that many good things to say about this drug.
The company tried to convince the FDA that PFS was an adequate surrogate for OS. The FDA wasn’t convinced but they agreed in a Special Protocol Assessment to an improvement over placebo control of 25% The company failed to meet this hurdle with only a very small numerical improvement that failed the agreed statistical mark, is of questionable clinical significance and failed to achieve the expected target even for placebo of 6 months of PFS. Match this non-significant improvement against the adverse experience profile and it’s impossible to see how this drug can be viewed as having a positive benefit risk.