AbbVie and J&J claim new Imbruvica okay in US

AbbVie and Johnson & Johnson’s Imbruvica has become the first chemo-free treatment for first-line chronic lymphocytic leukemia (CLL) to be approved by the FDA, its tenth indication. The green light from the US regulator is for a regimen based on BTK inhibitor Imbruvica (ibrutinib) and Roche’s anti-CD20 drug Gazyva (obinutuzumab) in CLL – the most common form of leukemia – as well as a related disease called small lymphocytic lymphoma (SLL). The approval is based on the results of the phase III iLLUMINATE study – presented at the American Society of Haematology (ASH) meeting in December – which showed that the duo reduced the risk of disease progression or death by 77% compared to the combination of Gazyva plus the chemotherapy chlorambucil in treatment-naïve patients.
It’s very much an add-on indication for Imbruvica, which is already used as a monotherapy in first-line CLL as well as a combination with chemotherapy plus Roche’s older CD20 drug Rituxan (rituximab) and allows J&J and AbbVie to double-down on their already-dominant position in first-line CLL. In addition to the Imbruvica/Gazyva combination, AbbVie and Roche are also running a trial (CAPTIVATE) of AbbVie’s BCL-2 inhibitor Venclexta (venetoclax) with Imbruvica which could provide yet another front-line option for CLL patients. Venclexta was approved as a monotherapy alongside Rituxan in relapsed CLL last year, and recently reported positive first-line results alongside Gazyva in the CLL14 study.