Janssen chalks up two more indications in Europe for Imbruvica combo therapies

pharmafile | August 14, 2019 | News story | Research and Development, Sales and Marketing Europe, Janssen, chronic lymphocytic leukaemia, imbruvica, pharma 

Janssen’s has secured a label expansion from the European Commission for its Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), approving the therapy in two new indications.

The ruling authorises Imbruvica in combination with obinutuzumab for the treatment of chronic lymphocytic leukaemia (CLL), and in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), both in adult patients. The drug was jointly developed by Janssen and AbbVie’s Pharmacyclics.

Following a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) back in June earlier this year, the decision was based on Phase 3 data from two separate trials: one comparing Imbruvica plus obinutuzumab to chlorambucil plus obinutuzumab in CLL, and Imbruvica plus rituximab to rituximab plus placebo in WM.

“The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively,” said Dr Alessandra Tedeschi, an investigator on the studies and Medical Director at the Department of Hematology, Niguarda Hospital in Milan. “These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers.”

Janssen’s Dr Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Oncology, also commented: “With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients. We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies.”

Matt Fellows

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