KRYPOLIS (carfilzomib) recently received conditional approval in China for the treatment of relapsed/refractory (R/R) multiple myeloma. Licensed by BeiGene, this drug is indicated for adults with R/R multiple myeloma who have already received a minimum of two therapies, including immunomodulatory agents and proteasome inhibitors. In addition, KRYPOLIS must be taken with dexamethasone.
Approval for KRYPOLIS
The China National Medical Products Administration (NMPA) has conditionally approved KRYPOLIS based on the results of a Phase 3 trial. This trial, which took place in China, enrolled 123 R/R multiple myeloma patients in order to investigate the safety and efficacy of KRYPOLIS in combination with dexamethasone.
The primary endpoint – overall response rate (ORR) – was met with a statistic of 35.8%. Progression-free survival (PFS) was 5.6 months, and the safety profile remained consistent with previous trials of the drug. No new adverse events or other safety risks were discovered in this latest trial.
To achieve full approval, a confirmatory study must be conducted. Until then, R/R multiple myeloma patients in China will still have access to KRYPOLIS. The President, General Manager of China, and COO at BeiGene, Dr. Xiaobin Wu, stated
The approval of KYPROLIS provides us with an important opportunity to offer adult patients in China with relapsed or refractory multiple myeloma a proteasome inhibitor with high selectivity and irreversibility as a treatment option for their disease.
About Multiple Myeloma
Multiple myeloma forms within plasma cells, which are a type of white blood cell that helps to fight infection. These malignant cells then crowd and push healthy cells out of the bone marrow, where they produce abnormal antibodies called M proteins. Medical professionals are unsure as to why this happens, but research has revealed that many myeloma cells are partially or completely missing chromosome 13.
Symptoms include:
- Nausea
- Fatigue
- Weight loss
- Frequent infections
- Hypercalcemia
- Confusion
- Constipation
- Loss of appetite
- Kidney problems
- Bone pain
- Low blood count
- Excessive thirst
- Numbness or weakness in the legs
There are five different categories of drugs that may be prescribed to treat multiple myeloma: HDAC inhibitors, proteasome inhibitors, steroids, chemotherapy, and immunomodulatory drugs. In addition, doctors will utilize supportive care.
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