CHMP Allows Amgen to Add Overall Survival Data to Kyprolis (carfilzomib) Label.
M2 PHARMA-February 2, 2018-CHMP Allows Amgen to Add Overall Survival Data to Kyprolis (carfilzomib) Label
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- Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) has received a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending a label variation for Kyprolis (carfilzomib) to include updated overall survival data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (Kyprolis and dexamethasone [Kd] versus Velcade [bortezomib] and dexamethasone [Vd]), the company said.
The ENDEAVOR trial demonstrated that Kd reduced the risk of death by 21% and increased overall survival (OS) by 7.6 months versus Vd in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01).
Kyprolis is approved in the European Union for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
The Kd regimen of twice-weekly Kyprolis administered at 56 mg/m2 and the KRd regimen of twice-weekly Kyprolis administered at 27 mg/m2 are the first and only therapeutic combinations to demonstrate consistently improved OS versus recent standards of care in two Phase 3 trials in relapsed or refractory multiple myeloma patients (Kd versus Vd and KRd versus lenalidomide and dexamethasone).
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.
Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.
With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
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|Date:||Feb 2, 2018|
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