Micrograph of B-cell chronic lymphocytic leukaemia/small cell lymphoma. Credit: Nephron.

AbbVie and Janssen Pharmaceutical have announced the US Food and Drug Administration (FDA) has approved Imbruvica in combination with obinutuzumab (Gazyva) for the treatment-naïve adults with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

This is said to be the first approval of a non-chemotherapy combination treatment for previously untreated CLL/SLL patients.

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Imbruvica is an oral, once-daily Bruton’s tyrosine kinase (BTK) inhibitor, which is jointly developed and commercialised by AbbVie subsidiary Pharmacyclics and Janssen Biotech.

The latest approval expands the drug’s existing label as a monotherapy or in combination with bendamustine and rituximab (BR) for CLL/SLL patients.

Janssen Research & Development clinical development and global medical affairs vice-president Craig Tendler said: “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.”

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The FDA approval comes after a review of data from the Phase III iLLUMINATE clinical trial that compared the safety and efficacy of Imbruvica-obinutuzumab combination with chlorambucil-obinutuzumab combination in around 212 patients.

“This label update builds upon the established efficacy and safety of Imbruvica in the frontline treatment of patients with CLL/SLL.”

At median follow-up of 31 months, Imbruvica in conjunction with obinutuzumab demonstrated significant improvement in progression-free survival (PFS), compared to chlorambucil plus obinutuzumab.

Participants in the Imbruvica arm achieved a 77% decrease in risk of progression or death, while those with high-risk disease experienced nearly 85% reduction, the companies said.

The FDA also expanded the the drug’s label based on long-term efficacy follow-up data from the Phase III RESONATE and RESONATE-2 studies, which supported its use as a monotherapy in CLL/SLL.

In addition to CLL and SLL, the drug holds FDA approvals for Waldenström’s macroglobulinemia (WM), as well as previously-treated mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) chronic graft-versus-host disease (cGVHD).

It is also approved as a monotherapy for MCL and WM in Europe, as well as alone and in combination for CLL.