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 + 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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Ref: AstraZeneca  | Image: StraitTimes