Application submitted for drug to treat androgen-independent prostate cancer

GPC Biotech AG has completed its rolling submission of a new drug application to the FDA for its oral formulation of satraplatin for the treatment of patients with androgen-independent prostate cancer who have failed prior chemotherapy.

The application is based primarily on data from the Satraplatin and Prednisone Against Refractory Cancer (SPARC) phase III registrational trial. The trial enrolled 950 patients, and showed highly statistically significant results for prolonging progression-free survival.

In the study, satraplatin plus prednisone is being compared with placebo plus prednisone as a second-line treatment in hormone-refractory prostate cancer. The study data show that the results for progression-free survival are statistically significant (p<.00001) using the protocol-specified log-rank test.

The most common adverse reactions in the SPARC trial were mild to moderate myelosuppression, gastrointestinal events, and fatigue.