AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation for Chronic Lymphocytic Leukemia

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation for Chronic Lymphocytic Leukemia

Shots:

  • The BT designation was based on two studies. The P-III ELEVATE-TN (ACE-CL-007) study involves assessing of Calquence as monothx. or in combination with obinutuzumab vs chlorambucil + obinutuzumab in 535 patients in a ratio (1:1:1) with previously untreated CLL
  • The P-III ASCEND (ACE-CL-309) study involves assessing of Calquence (100mg, qd) as monothx. vs rituximab + idelalisib/ bendamustine in 310 patients in a ratio (1:1) in previously treated patients with CLL
  • Calquence is a BTK inhibitor, act by binding covalently to BTK further inhibiting its activity in the beta cell and has received the US FDA’s accelerated approval for prior treated patients with MCL in Oct’2017 with its expected regulatory submission in H2’19

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Delaware Online