AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Approval for the Treatment of Blood Cancers
Shots:
- The US FDA has approved Calquence as a new tablet formulation for all current indications incl. CLL, SLL & r/r MCL
- The approval was based on the (ELEVATE-PLUS) trials evaluating Calquence in 116 healthy patients which showed that acalabrutinib 100mg tablets were bioequivalent to the currently marketed acalabrutinib 100mg capsules indicating the same efficacy & safety profile with the same dosing strength. The tablet can be taken with gastric acid-reducing agents, incl. PPIs, antacids & H2-receptor antagonists & no new safety signals were reported
- Calquence is also approved as a capsule formulation for the same indications & as the tablet in the US and other countries globally
Ref: AstraZeneca | Image: AstraZeneca
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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.
