FDA expands Imbruvica label with new survival data

pharmafile | May 11, 2016 | News story | Research and Development, Sales and Marketing AbbVie, FDA, Janssen, data, efficacy, expanded, imbruvica, label, late stage, phase III 

The US Food and Drug Administration (FDA) has expanded the label of Imbruvica (ibrutinib) to include the data from recent trials supporting its use in patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

The drug, developed by Janssen and AbbVie, performed well in Phase III trials, both as a single treatment and in combination.

Data from the RESONATE-2 trial showed a statistically significant 56% reduction in the risk of death with Imbruvica compared to chlorambucil. This formed the basis of an FDA approval for the drug in cases of CLL/SLL in March. Lead investigator of the study, Dr Jan Burger, commented: “The progression-free survival data seen in these previously untreated CLL patients are strong and encouraging. This is especially important for first-line CLL patients.”

The HELIOS study also supported the use of Imbruvica in combination with other therapies, which has now been added to the label.

Peter Lebowitz, global oncology head at Janssen R&D, says: “The clinical development plan for Imbruvica is very robust and includes many Phase II and III clinical trials across various indications and combinations. In partnership with Pharmacyclics, an AbbVie company, we continue to explore the clinical utility of Imbruvica and potential benefit it offers to patients with CLL/SLL and other haematologic malignancies.”

Burger adds: “This update helps to affirm the established efficacy, safety and tolerability of this therapy for the treatment of patients with CLL/SLL, both as a monotherapy or in combination with other agents.”

Sean Murray

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