AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First CT Free Treatment for 1L+ CLL/SLL

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 or death of patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV), and were presented at ASH 2018
• Imbruvica (ibrutinib) 420mg is an oral qd therapy which inhibits Bruton’s tyrosine kinase (BTK) and has received its 10 FDA approval. The approval also includes its usage as a single agent with the results of P-III RESONATE (PCYC-1112) and RESONATE-2 (PCYC-1115, PCYC-1116) study

Click here to read full press release/ article | Ref: Abbvie | Image: Stats