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J&J pushes to expand Imbruvica label after clinical success

Eyes the frontline setting in chronic lymphocytic leukaemia

Janssen J&J building

Johnson & Johnson has filed for approval of Imbruvica (ibrutinib) in combination with rituximab as a first-line treatment of chronic lymphocytic leukaemia (CLL).

Imbruvica, a Bruton’s tyrosine kinase (BTK) inhibitor, won approval in Europe in 2014. However, the current approval only covers the use of Imbruvica as a single agent or in combination with a chemotherapy drug, bendamustine, and rituximab in patients who have received at least one line of therapy.

The filing now awaiting review by the European Medicines Agency (EMA) stands to bring Imbruvica to a new set of patients. If successful, J&J, through its Janssen unit, will get approval to sell Imbruvica for use as a first-line treatment in combination with rituximab.

J&J is filing to expand the label on the strength of data from a clinical trial that compared Imbruvica and rituximab to the chemo-immunotherapy FCR in 529 previously untreated CLL patients aged 70 years or younger.

Progression-free survival at three years in the Imbruvica arm was 89.4%, as compared to 72.9% in the control cohort. The rates of overall survival at three years in the Imbruvica and control cohorts were 98.8% and 91.5%, respectively.

With both results achieving statistical significance, J&J thinks it has the evidence to support the use of Imbruvica in frontline settings. The expanded label would also support the use of Imbruvica in a combination that lacks a chemotherapy component, thereby advancing one of J&J goals for its drug.

“We remain committed to replacing long-standing use of chemotherapy with ibrutinib-based combination regimens for the treatment of patients with CLL in the frontline setting,” Craig Tendler, vice president, clinical development and global medical affairs at Janssen Research & Development, said in a statement.

That effort gained a boost last year when the US Food and Drug Administration (FDA) approved Imbruvica in combination with Gazyvaro (obinutuzumab) for use as a frontline treatment for CLL. The approval marked the first time a non-chemotherapy-based regimen had been cleared for use in treatment-naive CLL patients and continued a run of label expansions.

Imbruvica has received ten FDA approvals since coming to market late in 2013. The label expansions have helped J&J grow sales of the drug – over the first nine months of 2019, global sales increased by around one third to $2.5bn (€2.2bn).

Article by
Nick Taylor

20th January 2020

From: Regulatory



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