Rare Disease Report

Updated OS Data Added to Kyprolis Label After EMA Positive Opinion

JANUARY 30, 2018
Mathew Shanley
This morning, Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for recommending a label variation for Kyprolis (carfilzomib).

The new label will include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma. Last week, the same change was made in the United States after the U.S. Food and Drug Administration (FDA) approved Amgen’s supplemental New Drug Application (sNDA).

"The positive opinion issued by the CHMP for KYPROLIS, which, in combination with dexamethasone, achieved superior overall survival versus Velcade and dexamethasone, underscores our commitment to helping patients live better, longer lives," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen in a press release. "We're proud to share these results with European regulatory authorities and believe KYPROLIS is advancing the standard of care for patients with relapsed or refractory multiple myeloma."

Carfilzomib is approved in the European Union (EU) for use in combination with dexamethasone or with lenalidomide plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory myeloma who have received at least one prior therapy.

In multiple myeloma, the cancer forms in the plasma cells, resulting in an accumulation in the bone marrow. It is characterized by a recurring pattern of remission and relapse, and carilzomab has been proven to break down damaged or unnecessary proteins and block proteasomes.

929 patients were evaluated in the randomized ENDEAVOR trial across 235 sites worldwide , and each was dosed with carfilzomib in combination with low-dose dexamethasone versus bortezomib with low-dose dexamethasone in relapsed or refractory patients who previously received at least one, but not more than three, prior therapeutic regimens. The trial demonstrated that Kyprolis and dexamethasone (Kd) reduced the risk of death by 21% and increased OS by 7.6 months compared to Velcade and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma.

“Overall survival is generally considered to be the gold standard of endpoints because it clearly demonstrates a drug's value in extending a patient's life," said Reese in response to the FDA’s decision.

Kyprolis was first approved in 2012, and 50,000 patients have received it since. According to the National Cancer Institute, an estimated 30,280 Americans are diagnosed with multiple myeloma annually, and 12,590 patient deaths are reported each year.

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