Kyprolis is filed at FDA and EMA to treat relapsed Multiple Myeloma- Amgen + Onyx Pharma

Amgen and its subsidiary Onyx Pharmaceuticals announced the submission of a supplemental New Drug Application (sNDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kyprolis (carfilzomib) for injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

In the USA, the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union (EU), Kyprolis received orphan drug designation and the MAA has been granted accelerated assessment. The sNDA and MAA are based on data from the Phase III ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data.