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Janssen gets EC approval for expanded use of IMBRUVICA (ibrutinib) plus rituximab to treat CLL

Data from Phase 3 E1912 study showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab lived longer without disease progression than those treated with a chemo-immunotherapy regimen of fludarabine, cyclophosphamide and rituximab

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved a variation to the marketing authorisation for IMBRUVICA (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients. The decision is based on data from the Phase 3 E1912 study that showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR). The study was designed and conducted in the US by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the US National Institutes of Health.

The study evaluated 529 previously untreated patients with CLL aged 70 years or younger (median age, 58 years) who were randomly assigned to receive six cycles of ibrutinib plus rituximab (IR) (n=354), followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR (n=175).2

At a median follow-up of 37 months, patients treated with IR lived longer without disease progression, with progression-free survival (PFS) rate of 88 per cent, compared to 75 per cent for patients treated with FCR (hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.22-0.52; p<0.0001).1 The study also showed overall survival (OS) advantage for patients treated with the IR regimen.1 The primary study results were published previously in The New England Journal of Medicine, and with extended 48-month follow-up, as presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the initial treatment benefit is maintained.2,3

“This new non-chemotherapy combination regimen can offer extended remission, as well as fewer chemotherapy-related side effects for patients living with CLL,” said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag.”

Adverse events for the IR arm were consistent with the known safety profiles for ibrutinib and rituximab. The most common adverse reactions seen with ibrutinib include diarrhoea, neutropaenia, musculoskeletal pain, rash, haemorrhage (e.g., bruising), thrombocytopenia, nausea, pyrexia, arthralgia, and upper respiratory tract infection. The most common serious adverse reactions (which may affect more than 1 in 20 people) include neutropenia, lymphocytosis, thrombocytopenia, pneumonia, and hypertension.

“Ibrutinib is the most comprehensively studied Bruton’s tyrosine kinase (BTK) inhibitor with the longest follow-up across eight positive Phase 3 trials in CLL to date and is recognised as an important advancement in treatment for patients with CLL,” said Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development.

This announcement comes after the US Food and Drug Administration’s (FDA) approval of this expanded indication for ibrutinib in April 2020.

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