Onyx Pharmaceuticals is delaying its NDA filing for multiple myeloma drug carfilzomib until at least mid-year 2011 following FDA questions about the drug's manufacturing. The company had originally planned to submit its application by the end of 2010.
The FDA wants more data from Onyx proving that the developer can produce larger commercial batches of the drug that match the smaller amounts it produced for clinical trials. The company made manufacturing process changes as it prepared to scale up carfilzomib production. But in a recently manufacturing-scale run, Onyx found variations that are believed to be primarily related to equipment temperature variances. In a statement, the company stresses that the clinical profile of carfilzomib has not changed, and no new safety signals have been observed.
"We are confident in the clinical and preclinical data package supporting the carfilzomib NDA and in our manufacturing strategy," says CEO N. Anthony Coles in a statement. "We believe that by providing this supportive data, we will strengthen our NDA package, thus enabling us to bring carfilzomib to patients with multiple myeloma as quickly as possible."
Xconomy notes that carfilzomib is an important asset to Onyx as the company attempts to diversify beyond its blockbuster cancer drug Nexavar. Last year, Onyx struck a deal to buy the cancer drug developer Proteolix for $276 million down and up to $575 million more for development and regulatory milestones.
- see Onyx's release
- here's the Xconomy piece for more