EU regulator extends carfilzomib’s approval for multiple myeloma4 Jul 2016
The European Commission (EC) has approved a variation to the marketing authorization for carfilzomib to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication follows its initial release in November 2015, and marks the second approval for carfilzomib by the EC in less than a year.
“In the Phase 3 head-to-head trial, carfilzomib in combination with dexamethasone doubled the time patients lived without their cancer progressing, as well as the rates of complete response compared to bortezomib and dexamethasone,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, who own the branded carfilzomib as Kyprolis. “Carfilzomib-based regimens have now shown superiority over two former standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing carfilzomib’s place as a foundational therapy in this patient population.”
Positive patient outcomes supporting the approval
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. It is a rare and very aggressive disease that accounts for approximately 1% of all cancers worldwide. In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.
The EC approved the extended indication for carfilzomib based on data from the Phase 3 head-to-head ENDEAVOR trial in which patients with multiple myeloma treated with carfilzomib plus dexamethasone (Kd) achieved superior progression-free survival of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone (Vd).
Kd also demonstrated improvement over Vd for secondary endpoints, including rates of complete response or better, which were double in patients treated with Kd compared to those treated with Vd. The tolerability profile was similar in the two arms, however patients treated with Kd experienced a significantly lower rate of grade 2 or higher neuropathy events than those treated with Vd, a frequent dose-limiting toxicity in patients receiving bortezomib.
What about the common adverse events?
The most common adverse reactions that occurred in greater than 20% of patients treated with carfilzomib were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.
Carfilzomib was first approved by the EC in November 2015 for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy based on results of the ASPIRE study.
This approval by the EC follows the U.S. FDA’s approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.
Source: eCancer News