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EMA accepts MAA for Amgen’s myeloma drug Kyprolis

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) of Amgen and Onyx Pharmaceuticals' Kyprolis (carfilzomib) for Injection to treat patients with relapsed multiple myeloma who have received at least one prior therapy.

Kyprolis is a product of Amgen’s subsidiary Onyx Pharmaceuticals, which holds global development and commercialization rights to the product, excluding Japan.

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."

The MAA, which includes data from the Phase III ASPIRE trial as well as other relevant data, has been granted accelerated assessment by the EMA.

A total of 792 patients were enrolled in the international, randomized Phase III ASPIRE trial at sites in North America, Europe and Israel.

The trial evaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens.

The trial’s primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life and safety.

Earlier, Kyprolis had secured orphan drug designation from the EMA in the European Union (EU).

Kyprolis was granted accelerated approval by the US Food and Drug Administration (FDA) in July 2012, and is also approved for use in Argentina, Israel and Mexico.