Shots:

• The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
• ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
• Calquence is a selective inhibitor of BTK- binds covalently to BTK- thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020

 ­ Ref: AstraZeneca | Image: Al Jazeera