This clinical submission is based on data from a phase III registrational trial. The trial results for progression-free survival (PFS) were highly statistically significant.
Satraplatin was granted fast track status, which allowed the FDA to accept a rolling new drug application. Upon acceptance, the FDA will determine if the application will be granted priority review, which would allow for a six-month review of the application.
The FDA’s acceptance of the application will trigger a $4 million milestone payment to Spectrum. Spectrum is also entitled to receive milestone payments upon the achievement of additional regulatory milestones in the US, Europe, Japan and other countries.
Further payments are due on achieving certain sales targets and Spectrum is entitled to receive royalties on worldwide sales of satraplatin. The company also has co-promotion rights in the US, if its partner markets satraplatin in the US.