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January 29, 2019

AbbVie and Janssen’s Imbruvica secures expanded FDA approval

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).

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.

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.”

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.

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