http://www.raredr.com/news/fda-adds-os-data-to-kyprolis-label
FDA Adds Overall Survival Data to Kyprolis Label

Mathew Shanley

Last night, the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for Kyprolis (carfilzomib).

Multiple myeloma forms in the plasma cells, causing cancer to accumulate in the bone marrow. Symptoms most commonly include bone pain, nausea, constipation, loss of appetite, cognitive impairment, and excessive thirst.

Kyprolis has been proven to block proteasomes, which are essential to cell function and growth by breaking down damaged or unnecessary proteins, resulting in an excessive build-up of proteins within cells. In some cases, Kyprolis has caused cell death, especially in myeloma cells which are more likely to contain a higher number of abnormal proteins.

"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 David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen in a press release. "Blood cancer therapies approved by the FDA between 2003 and 2013 only improved overall survival by an average of 2.61 months.3 KYPROLIS and dexamethasone improved overall survival by 7.6 months, underscoring that this regimen is a significant advancement and should be considered a standard of care for patients with relapsed or refractory multiple myeloma."

The ENDEAVOR trial enrolled 929 patients and evaluated Kyprolis in combination with low-dose dexamethasone compared to Velcade with low-dose dexamethasone in relapsed or refractory patients who were previously administered at least 1, but not more than 3 prior therapeutic regimens. Patients were provided treatment until progression with Kyprolis as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28-day treatment cycles, along with low-dose dexamethasone (20 mg).

In addition to the latest approval, the latest edition of the Journal of Clinical Oncology recently published positive OS findings from the final analysis of the Phase 3 ASPIRE trial, which exhibited the addition of Kyprolis’ to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% compared to the two drugs alone. The addition also extended OS by 7.9 months in patients with relapsed or refractory multiple myeloma.

"As seen in two different Phase 3 studies, KYPROLIS-based regimens are the first and only therapy combinations to demonstrate a significant overall survival advantage for patients with relapsed or refractory multiple myeloma versus recent standards of care," said Reese at the time of the data’s publishing. "We look forward to continuing conversations with regulatory authorities in the U.S. and Europe to add these results to the KYPROLIS label."

Kyprolis is now approved in the U.S. for: in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy; and as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

The drug was first approved in 2012, and since then, more than 50,000 patients have received it worldwide. Per the National Cancer Institute, approximately 30,280 Americans are diagnosed with multiple myeloma each year, and 12,590 patient deaths are reported annually.

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