Celgene pulling Orplatna MAA

GPC (Xetra:GPC; NASDAQ:GPCB) said partner Celgene (NASDAQ:CELG) plans to withdraw an MAA for Orplatna satraplatin plus prednisone to treat hormone-refractory prostate cancer (HRPC) in patients who have failed prior chemotherapy. According to GPC, Celgene's decision was based on a list of outstanding issues received from EMEA's CHMP, which GPC said "indicates that the opinion of the Committee is that the application is currently not approvable."

Last July, GPC withdrew an NDA for Orplatna after an FDA advisory panel recommended the agency wait for overall survival data from the Phase III SPARC trial prior to deciding on whether to grant approval. Results from the SPARC study reported in October showed that Orplatna plus prednisone did not improve overall survival vs. placebo and prednisone (See BioCentury Extra, Wednesday, Oct. 31, 2007). ...