Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) has recently completed submission of its New Drug Application (NDA) to the USFDA for satraplatin.
Satraplatin is Spectrum Pharma’s lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) in patients who have failed prior chemotherapy.
Fast-track status was granted to satraplatin, which allowed the FDA to accept a rolling NDA. This submission is the third and final portion of the said rolling NDA.
According to Rajesh C. Shrotriya, M.D., Spectrum's President and Chief Executive Officer:
"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."
Satraplatin is a fourth-generation member of the platinum family of compounds. Unlike current platinum compounds that are intravenously administered, satraplatin is an oral drug.
Find more details from the press release.
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