Amgen Submits Applications in the US and Europe for Kyprolis (Carfilzomib) for the Treatment of Relapsed Multiple Myeloma

Amgen and its subsidiary Onyx Pharmaceuticals have announced the submission of a supplemental New Drug Application (sNDA) to 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 US, 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.

"Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing," said Pablo J. Cagnoni, President, Onyx Pharmaceuticals. "The US and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma."

Kyprolis is in a class of drugs called proteasome inhibitors and was granted accelerated approval by the FDA in 2012. Kyprolis is also approved for use in Argentina, Israel and Mexico.