FDA Priority Review Granted for Expanded Use of Amgen’s Kyprolis


US health regulators have granted priority review to Amgen’s supplemental new drug application (sNDA) for its multiple myeloma drug.

Amgen said that the US Food and Drug Administration (FDA) has accepted the sNDA of Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. As part of the acceptance, the agency has granted the drug priority review and will make its final decision on the application by July 26.

The current sNDA is designed to support conversion to full approval and expand the use of Krypolis, which is already approved for multiple myeloma patients who have received at least two prior therapies, including bortezomin and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy.

The sNDA includes data from the late-stage ASPIRE trial, which 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 of three prior regimens. In the Phase III trial, the median progression-free survival (PFS), the primary endpoint of the study, with Kyprolis was 26.3 months compared to 17.6 months. Additionally, the objective response rate was 87.4 percent versus 66.9 percent and the median duration of response was 28.6 months compared with 21.2 months with and without Kyprolis, respectively.

“Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “The FDA’s priority review designation for Kyprolis underscores the need for new treatment options for patients with relapsed multiple myeloma, and we look forward to working with regulatory authorities throughout the review process.”

Amgen gained rights to Kyprolis through its $10.4 billion acquisition of Onyx Pharmaceuticals in 2013. Last year, the drug generated worldwide annual sales of $331 million.

Multiple myeloma is the second most common hematologic cancer, affecting nearly 230,000 people worldwide. Additionally, approximately 114,000 new cases of multiple myeloma are diagnosed annually.

Source: Amgen

Last updated: 3/31/15; 11:05am EST

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