7.26.2007

FDA Oncologic Drugs Advisory Committee Recommends that FDA Wait for Overall Survival Results from Satraplatin Phase 3 Trial

FDA Oncologic Drugs Advisory Committee Recommends that FDA Wait for Overall Survival Results from Satraplatin Phase 3 Trial: "MARTINSRIED/MUNICH, Germany, July 24 /PRNewswire-FirstCall/ -- U.S. Subsidiary Headquarters at Princeton, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether the satraplatin application is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. The FDA is not bound by the recommendations of advisory committees but will consider their advice when reviewing an applicant's NDA."