It appears that Amgen’s Kyprolis (carfilzomib) is even better than first thought at treating multiple myeloma. And if Amgen has its way, their drug will replace Takeda Oncology’s Velcade (bortezomib) as the treatment of choice for patients with relapsed or refractory multiple myeloma.
Amgen announced the results of their 3-year post hoc analysis assessing the overall survival (OS) in patients with relapsed or refractory multiple myeloma who were part of the Phase 3 clinical trial that previously showed that Kyprolis significantly improved progressive-free survival (PFS) compared to Velcade. That new post-hoc analysis, requested by the U.S. Food and Drug Administration (FDA), is also part of a supplemental New Drug Application (sNDA) the company has submitted to the FDA.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, 2018 to decide on the data.
The post-hoc analysis data showed that Kyprolis (carfilzomib) and dexamethasone reduced the risk of death by 21% and increased overall survival (OS) by 7.6 months compared to Velcade
(bortezomib) and dexamethasone treatment. Median OS in the Kyprolis and dexamethasone treated group was 47.6 months versus 40.0 months in the Velcade
and dexamethasone treated group (HR=0.79; P =
Currently Kyprolis is approved for:
- 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.
Multiple Myeloma is a cancer that forms in the plasma cells that causes cancer cells to accumulate in bone marrow. Symptoms include bone pain, nausea, constipation, loss of appetite, mental issues and excessive thirst. It is a rare and very aggressive disease that accounts for approximately 1% of all cancers.
If the sNDA is approved by the FDA, the prescription information will include the overall survival data and likely sway clinicians to choose Kyprolis over Velcade for multiple myeloma patients who have relapsed or refractory.
In a news release
, Robert Orlowski, M.D., Ph.D., Florence Maude Thomas Cancer Research professor and chair, ad interim, Department of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center said, "The current three-year follow-up analysis demonstrates that this proteasome inhibitor continues to demonstrate a prolonged overall survival benefit and consistent safety profile when combined with dexamethasone for relapsed multiple myeloma patients."
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen added, "These results confirm that when a patient relapse, Kyprolis should replace Velcade as a standard-of-care."
The most common adverse events (greater than or equal to 20%) in the Kyprolis treated group were anemia, diarrhea, pyrexia, hypertension, dyspnea, fatigue, cough, insomnia, upper respiratory tract infection, nausea, bronchitis, asthenia, back pain, thrombocytopenia, edema peripheral, headache and muscle spasms.
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