The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a label variation for KYPROLIS® (carfilzomib) to include the final overall survival data, following a recent Phase III trial.
KYPROLIS® is the first and only relapsed or refractory multiple myeloma treatment to demonstrate overall survival (OS) in two Phase III studies, Amgen, the American multi-national biopharmaceutical company, has announced [April 30].
The Phase III ASPIRE trial demonstrated that the addition of KYPROLIS to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% versus lenalidomide and dexamethasone alone (Rd), and extended overall survival by 7.9 months in patients with relapsed or refractory multiple myeloma. (Median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95; 1-sided p=0.0045).
“This latest positive CHMP opinion marks the second time Amgen will add overall survival data from a Phase III study to the label, further validating the fundamental role of KYPROLIS in treating patients with relapsed or refractory multiple myeloma,” said David M. Reese, senior vice president of Translational Sciences and Oncology at Amgen.
“This is a major step towards advancing KYPROLIS-based regimens as standard of care, and we look forward to the European Commission’s decision later this year.”
KYPROLIS is approved in the European Union (EU) for use in combination with lenalidomide and dexamethasone or with dexamethasone alone (Kd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The Kd regimen of twice-weekly KYPROLIS administered at 56mg/m2 and the KRd regimen of twice-weekly KYPROLIS administered at 27mg/m2 are the first and only therapeutic combinations to demonstrate consistently improved OS versus recent standards of care in two Phase III trials in relapsed or refractory multiple myeloma patients (Kd versus bortezomib and dexamethasone [Vd] and KRd versus Rd), Amgen said.
Since its approval in 2012, approximately 80,000 patients worldwide have received KYPROLIS. The KYPROLIS clinical program continues to focus on providing treatment options for physicians and patients for this frequently relapsing and difficult-to-treat cancer.
The study results were published in the Journal of Clinical Oncology.
