AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation to Treat Chronic Lymphocytic Leukaemia (CLL) in Adults

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  • 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 + idelalisib/ bendamustine in 310 patients in ratio (1:1) with previously untreated patients with CLL
  • The two P-III trials ELEVATE-TN and ASCEND trials resulted in positive data showed increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile and will serve as the foundation for regulatory submissions later this year
  • Calquence (acalabrutinib) is a Bruton tyrosine kinase (BTK) inhibitor and is developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, FL, and MM and other haematologic malignancies

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