Amgen announced on the 27th August, 2018 the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the Prescribing Information for Betadex Sulfobutyl Ether Sodium (SBECD, Captisol, Dexolve) enabled KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma. The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS administered once-weekly at 70 mg/m2 with dexamethasone achieved superior progression-free survival and overall response rates, with a comparable safety profile versus the twice-weekly KYPROLIS at 27 mg/m2 and dexamethasone.
The FDA is reviewing the application under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
The trial was conducted in approximately 100 sites worldwide. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT02412878.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. It is a rare and life-threatening disease that accounts for approximately one percent of all cancers. Worldwide, approximately 114,000 people are diagnosed with multiple myeloma each year and 80,000 patient deaths are reported on an annual basis.
About KYPROLIS® (carfilzomib)
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.
Since its first approval in 2012, approximately 80,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:
- In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
- As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
KYPROLIS is also approved in Argentina, Australia, Bahrain, Canada, Hong Kong, Israel, Japan, Kuwait, Lebanon, Macao, Mexico, Thailand, Colombia, S. Korea, Canada, Qatar, Switzerland, United Arab Emirates, Turkey, Russia, Brazil, India, Oman and the U.S. Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.