Tags : CLL

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

AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First

Shots: The combinational approval is based P-III iLLUMANTE (PCYC-1130) study results assessing Imbruvica + Gazyva vs chlorambucil + Gazyva in patients with 1L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) aged ≥ 65 years The P-III iLLUMANTE study resulted in 77% reduction in risk of progression or death and has also shown 85% reduction in progression […]Read More