- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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