Onyx Pharmaceuticals is to delay filing for approval for blood-cancer drug carfilzomib following a request from the US Food and Drug Administration for additional information.
The agency is seeking more details on variations the company identified in the temperature control of the equipment used to manufacture the drug, according to online.wsj.com.
Onyx had been expected to file for approval by the end of the year, but now expects to seek accelerated approval by the middle of the next year.
The company confirmed that the drug's clinical trials are still on schedule.
Carfilzomib was originally developed by Proteolix, which Onyx acquired in 2009 for $276m plus potential milestone payments.