Tags : acalabrutinib

AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III ELEVATE TN

Shots: The P-III ELEVATE TN study involves assessing of Calquence + obinutuzumab / Calquence as monothx. vs chlorambucil + obinutuzumab in 535 patients in a ratio (1:1:1) with previously untreated CLL aged ≥65yrs. or b/w 18-65yrs. with CIRS> 6 or creatinine clearance of 30-69 mL/min Results: @24mos.patients remained free of disease progression or death (93%/ […]Read More

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Approval for Chronic

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 […]Read More

AstraZeneca Canada’s Calquence (acalabrutinib) Receives Health Canada Approval for Patients

Shots: The NOC is based on the positive data of Calquence in ACE-LY-004 trial demonstrating 81% OR rate for patients with relapsed or refractory MCL The Health Canada approval of Calquence allows AstraZeneca to develop the treatments of blood cancers Calquence (acalabrutinib, previously known as ACP-196) is an oral selective inhibitor of Bruton’s tyrosine kinase (BTK) […]Read More

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation

Shots: The FDA’s BT Designation is based on the P-III ELEVATE-TN assessing Calquence (100 mg, bid) as monothx or in combination with obinutuzumab vs chlorambucil + obinutuzumab and in 535 patients in ratio (1:1:1) in previously untreated patients with CLL and in another P-III ASCEND Trial (ACE-CL-309) involves assessing of Calquence (310 mg) vs rituximab […]Read More

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation

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 […]Read More