Celgene Withdraws European Marketing Application for Orplatna

Celgene Europe has told the European Medicines Agency (EMEA) that its Pharmion subsidiary is withdrawing a marketing application for Orplatna because the EMEA’s Committee for Medicinal Products for Human Use does not think the cancer drug’s benefits outweigh its risks.

Orplatna (satraplatin) 10-mg and 50-mg capsules were intended for use in combination with prednisone and prednisolone to treat metastatic hormone-refractory prostate cancer in patients who haven’t benefited from chemotherapy. The application was submitted to the EMEA in June 2007, several months before Celgene bought Pharmion.

GPC Biotech, a German company, has an Orplatna partnership with Celgene. In July 2007, the FDA’s Oncologic Drugs Advisory Committee recommended that the agency defer its decision on GPC’s NDA for Orplatna until the company submitted survival data.

GPC withdrew the NDA and last October announced that the drug had shown no survival benefit in patients with hormone-refractory prostate cancer in a Phase III clinical study testing the product as a second-line treatment.