Spectrum Pharmaceuticals Inc. has announced the completion of the submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) for satraplatin, the company's lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) for those patients who have failed prior chemotherapy.
This clinical submission, the third and final portion of the rolling NDA, is based on data from the SPARC (Satraplatin and Prednisone Against Refractory Cancer) phase 3 registrational trial. The trial enrolled 950 patients, and the study data results for progression-free survival (PFS) were highly statistically significant. Satraplatin was granted fast-track status, which allowed the FDA to accept a rolling NDA. The FDA has previously accepted major components of the NDA, including, chemistry, manufacturing and controls and non-clinical information for review.
The FDA has up to 60 days to formally accept the completed application. Upon acceptance, the FDA will determine if the application will be granted priority review, which has already been requested and would allow for a six-month review of the NDA.
The FDA's acceptance of the NDA 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. In addition to milestones, 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 itself in the US.
"The completion of the filing of the satraplatin NDA is an important landmark for Spectrum as we are now one step closer to bringing forth a new treatment option for patients with prostate cancer. The completion of this rolling NDA also validates our business model of identifying promising drug candidates and opportunistically advancing those candidates through clinical development," said, Rajesh C Shrotriya, MD, Spectrum's president and CEO "Beginning with the acceptance of this filing, Spectrum will be entitled to receive a series of milestone payments that will serve as a source of non-dilutive funding, a key part of our strategy for the advancement of our broad and deep pipeline of drugs. We plan to follow this strategy as we continue to develop our portfolio of 10 drug candidates, two of which are expected to be in phase 3 clinical trials this year: Ozarelix for benign prostate hypertrophy and EOquin for noninvasive bladder cancer."