MUNICH, Germany, Feb. 16 (UPI) -- German firm GPC Biotech said Friday it completed its rolling new drug application to the U.S. Food and Drug Administration for satraplatin.
GPC is developing the drug as treatment for patients with hormone refractory prostate cancer who have failed on chemotherapy.
"We believe that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients who today have very little hope," said Bernd Seizinger, GPC's CEO.
"We are currently building our commercial infrastructure in the United States to prepare for the potential launch of satraplatin so that it will be available for these patients as quickly as possible," Seizinger added.
GPC said its final portion of the NDA was based primarily on data from the SPARC phase 3 trial, which showed satraplatin prolonged progression-free survival.
