BeiGene-Amgen's Kyprolis Gets Approval In China For Pre-Treated Multiple Myeloma Patients

The China National Medical Products Administration (NMPA) has conditionally approved Kyprolis (carfilzomib) for relapsed or refractory (R/R) multiple myeloma.
The approval covers Kyprolis in combination with dexamethasone for adult patients who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.
Kyprolis is licensed to BeiGene Ltd BGNE in China under a strategic collaboration with Amgen Inc AMGN.
The conditional approval was based on results from the Phase 3 trial. Results showed that the overall response rate, the primary endpoint, was 35.8%.
The median progression-free survival (PFS) was 5.6 months.
Related content: Benzinga's Full FDA Calendar
Price Action: AMGN and BGNE shares closed at $244.28 and $320.11, respectively, on Thursday.