ARTICLE | Clinical News

Carfilzomib regulatory update

October 11, 2010 7:00 AM UTC

Onyx said it will delay a planned NDA submission for carfilzomib to treat relapsed and refractory multiple myeloma (MM) to as early as mid-2011 after FDA requested additional CMC information related to commercial-scale manufacturing during a pre-NDA meeting. The company had previously planned to submit the NDA by year end. Onyx said it observed minor variations during a manufacturing-scale run, which the company said are believed to be primarily related to equipment temperature variances. Onyx said no new safety signals for carfilzomib have been observed and that the changes are not expected to affect ongoing trials of the selective proteasome inhibitor. The company plans to request accelerated approval of the NDA. ...