The European Medicines Agency (EMA) has accepted US-based drugmaker Amgen’s marketing authorisation application (MAA) for Kyprolis (carfilzomib) for Injection to treat patients with relapsed multiple myeloma who have received at least one prior therapy.
Kyprolis is a proteasome inhibitor developed to treat multiple myeloma. It is a product of Onyx Pharmaceuticals , a subsidiary of Amgen.
Onyx Pharmaceuticals president Pablo Cagnoni said: "Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing.
"We look forward to working with European regulators to potentially make this important medication available."
The MAA comprises data from the Phase III Carfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of Patients with Relapsed Multiple Myeloma (ASPIRE) trial, in addition to other relevant data.
Earlier, Kyprolis obtained orphan drug designation by the EMA in the European Union (EU). It also received approval in Argentina, Israel and Mexico.
Kyprolis received accelerated approval from the US Food and Drug Administration (FDA) to treat patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD).
The randomised Phass III ASPIRE trial assessed Kyprolis in combination with lenalidomide and low-dose dexamethasone, against lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens.
The study randomised 792 patients at sites in North America, Europe and Israel. Its primary endpoint was progression-free survival and secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life and safety.
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