Imbruvica combo scores expanded FDA approval in most common adult form of leukaemia

pharmafile | January 29, 2019 | News story | Manufacturing and Production, Sales and Marketing AbbVie, Cancer, Janssen, imbruvica, leukaemia, pharma 

It’s big news for Janssen and AbbVie as it emerged that their jointly-developed Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) has been awarded expanded indication by the FDA when used in combination with obinutuzumab. The combo is now approved for the treatment of the most common form of adult leukaemia, chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), in treatment-naïve patients.

This latest approval marks the tenth for Imbruvica from the FDA since its 2013 US launch; it was previously only approved as a monotherapy in this indication. The latest decision drew upon Phase 3 data which illustrated that the combo produced a “significant improvement” in Independent Review Committee (IRC)-evaluated progression-free survival compared to chlorambucil plus obinutuzumab, with a 77% reduction in risk of disease progression or death.

Additionally, the combo showed an 89% IRC-evaluated overall response rate compared to 73% with chlorambucil plus obinutuzumab.

“In just a few years, Imbruvica has become an important treatment for chronic lymphocytic leukaemia. Imbruvica as a single agent – and now as a combination with obinutuzumab – provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy,” commented Dr Carol Moreno, the study’s lead investigator and Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona.

Dr Craig Tendler, Vice President of Clinical Development and Global Medical Affairs at Janssen, also remarked: “This label update builds upon the established efficacy and safety of Imbruvica in the frontline treatment of patients with CLL/SLL, as a monotherapy or in combination with other treatments. This milestone represents our continued commitment to develop Imbruvica-based, non-chemotherapy regimens to address the clinical needs of patients living with CLL/SLL.”

Matt Fellows

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