BeiGene, Ltd. [NASDAQ: BGNE] disclosed Friday that it has got the authorization from the China National Medical Products Administration (NMPA) for KYPROLIS. KYPROLIS has been approved in China for injection in combination with dexamethasone for the cure of adult sufferers with relapsed or refractory (R/R) multiple myeloma who have got at least two earlier therapies.
The two therapies that sufferers received include proteasome inhibitors and immunomodulatory agents. In addition to this, KYPROLIS is approved by BeiGene in China under a strategic partnership with Amgen. This is the first authorization for KYPROLIS in China. Multiple myeloma is an incurable and highly persistent hematological malignancy. Regrettably, the clinical requirements of sufferers in China with this disease have yet to be fully contented.
Furthermore, the conditional authorization of KYPROLIS was dependent on outcomes from the Phase III study (NCT03029234) in China. The study assesses the efficacy and safety of KYPROLIS plus dexamethasone in 123 sufferers with R/R multiple myeloma. The outcome of the study underscored that the efficacy in Chinese sufferers who had got a median of four prior lines of therapy was generally dependable with that witnessed in the global studies.
Moreover, the safety profile witnessed for Chinese sufferers in this trial was in line with that seen in the global trials assessing KYPROLIS in R/R multiple myeloma. In global studies, the most common unfavorable reactions in the combination therapy studies were anemia, diarrhea, fatigue, hypertension, etc. No new safety risks were discovered based on the evaluation of unfavorable events in Chinese sufferers. The complete authorization is dependent on the results of a confirmatory study.