This decision was based on a list of outstanding issues received following review by the Committee for Medicinal Products for Human Use of the European Medicines Agency of the filing, which indicates that the opinion of the committee is that the application is currently not approvable based on the information provided.
Bernd Seizinger, CEO of GPC Biotech, said: “Although we previously communicated that the approval of the marketing authorization application for satraplatin would be challenging, today’s outcome is nevertheless disappointing.
“We are working closely with our partners to determine the next steps regarding the development of satraplatin and continue to focus our other efforts on advancing our RGB-286638 kinase inhibitor into the clinic and exploring various merger and acquisition opportunities.”