AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia Under the Project Orbis

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia Under Project Orbis

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

Source 1, Source 2 to­ read full press release/ article | Ref: FDA, AstraZeneca | Image: China Daily