Amgen Submits Applications for Approval of its Multiple Myeloma Drug Kyprolis in the US and Europe

Amgen and its subsidiary Onyx Pharmaceuticals, Inc. recently announced that it has submitted applications to both US and EU health regulators for approval of Kyprolis (carfilzomib) for treatment of multiple myeloma.

The companies said that they have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kyprolis 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 application is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. The drug was granted accelerated approval by the FDA in 2012. In the EU, the drug received orphan drug designation and the MAA has been granted accelerated assessment.

The submission of the applications is based on positive results from the Phase III ASPIRE trial, which evaluated the drug 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 study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS), with patients treated with Kyprolis in combination with lenalidomide and low-dose dexamethasone demonstrating an 8.7 month improvement in PFS. Additionally, the study met all secondary endpoints, including overall survival (OS), overall response rate (ORR), duration of response (DOR), health-related quality of life (HR-QoL) measures and safety.

Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, typically in the bone marrow. Nearly 230,000 people are living with the disease worldwide. In 2012, approximately 114,000 new cases of multiple myeloma were diagnosed and 80,000 people died from the disease.

“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, MD, president, Onyx Pharmaceuticals, Inc. “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. The FDA granted it accelerated approval in 2012 for the treatment of patients with multiple myeloma who had received at least two prior therapies.

Source: Amgen

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