AstraZeneca’s Calquence (acalabrutinib) Receives the NMPA’s Approval for Mantle Cell Lymphoma
Shots:
- The NMPA has approved Calquence (BTK inhibitor) for adult patients with MCL. The approval was based on the 2 clinical trials, incl. the P-II trial (ACE-LY-004) for adults with r/r MCL & P-I/II trial in Chinese patients with r/r MCL & other B-cell malignancies evaluating Calquence (100mg)
- In the P-II trial, the results showed ORR (80.6%) at a median follow-up of 15.2mos. with a CR (39.5%) while the long-term follow-up data showed that patients remained progression-free for a median of 22mos. @38.1mos., m-OS of 59.2mos.
- In the P-I/II trial, ORR (82.4%), CR (35.3%), and 51.5% reduction in risk of disease progression or death at 12mos. with an estimated DoR of 65.5% & the m-DoR (not reached). The safety & tolerability were consistent with prior reported trials
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca’s Calquence (acalabrutinib) Receives the MHLW’s Approval for Treatment-Naïve Chronic Lymphocytic Leukaemia
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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.
