GPC BIOTECH COMPLETES NDA FILING FOR PROSTATE CANCER DRUG
GPC Biotech announced it has completed the rolling submission of a new drug application (NDA) to the FDA for satraplatin for the treatment of patients with androgen-independent prostate cancer who have failed prior chemotherapy.
The company submitted the third and final portion of the NDA -- the clinical section, which is based primarily on data from the SPARC Phase III registrational trial. The trial enrolled 950 patients and showed highly statistically significant results for prolonging progression-free survival. The FDA has up to 60 days to determine whether the application meets the regulatory requirements for filing.
Satraplatin is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound given as capsules that patients can take at home.
In September 2006 GPC Biotech announced positive top-line results from the double-blinded, randomized satraplatin Phase III registrational trial, the SPARC trial. The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer. The study data show that the results for progression-free survival are highly statistically significant using the protocol-specified log-rank test.