Shots:

• The US FDA in collaboration with TGA and Health Canada granted supplemental approval to AstraZeneca’s Calquence to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)- as the part of Project Orbis and Real-Time Oncology Review (RTOR) pilot program  
• The approval is based on two P-III studies- ELEVATE-TN & ASCEND assessing Calquence + obinutuzumab or Calquence as monothx vs chlorambucil + obinutuzumab & Calquence vs rituximab + idelalisib/ bendamustine in 535 & 310 previously treated patients with CLL respectively
• The two P-III studies demonstrated superior PFS across multiple settings while maintaining favorable tolerability while in ELEVATE -TN study- it resulted in 90% and 80%- reduction in risk of disease progression or death in combination and monothx. respectively. Calquence is a BTK inhibitor- act by binding covalently to BTK thus inhibiting its activity in beta-cell

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Ref: FDA- AstraZeneca | Image: AstraZeneca