AstraZeneca’s Calquence (acalabrutinib) Receives NMPA’s Approval for Chronic Lymphocytic Leukaemia in China
Shots:
- The approval was based on the P-III trial (ASCEND) evaluating Calquence vs idelalisib + rituximab (IdR) or bendamustine + rituximab (BR) in a ratio (1:1) in 310 patients & P-I/II trial of Calquence in adult Chinese patients with CLL
- In the P-III trial, 88% vs 68% were alive & free from disease progression after 12mos. while longer-term follow-up data showed 62% vs 19% were alive and had not progressed at 42mos. In the P-I/II trial, ORR (83.3%), and m-PFS (not reached) at a median follow-up of 20.2mos., 12 & 18mos. PFS rates (90.7% & 78.8%)
- The safety & tolerability were consistent with prior clinical trials. Calquence was approved in the US & Japan for CLL and SLL; for CLL in the EU & in multiple other countries globally in the treatment-naïve and R/R settings; in the US, China & multiple other countries for MCL
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca’s Calquence (acalabrutinib) Receives the NMPA’s Approval for Mantle Cell Lymphoma
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
