The European Commission (EC) has expanded the marketing authorisation for Janssen's Imbruvica (ibrutinib) to include treatment naïve patients with chronic lymphocytic leukaemia (CLL).
The decision follows data from the Phase III E1912 study, which shows that previously untreated adults aged 70 years or younger given the drug plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR).
The study assessed 529 previously untreated patients with CLL who were randomly assigned to receive six cycles of Imbruvica plus rituximab followed by Imbruvica until disease progression or unacceptable toxicity, or six cycles of FCR.
At a median follow-up of 37 months, patients treated with the Imbruvica regimen lived longer without disease progression, with a progression-free survival (PFS) rate of 88%, compared to 75% for patients treated with FCR.
“Historically, chemotherapy with FCR has been the standard of care, or first treatment prescribed for patients with previously untreated CLL,” said John Gribben, Professor of Medical Oncology at St Bartholomew's Hospital, Barts Cancer Institute, Queen Mary, University of London. “This decision by the EC is an important step in being able to offer patients with CLL a non-chemotherapy option in the frontline setting, building on the established efficacy and safety we have come to expect from ibrutinib-based therapy.”
“We are delighted with the EC’s decision approving the use of ibrutinib in combination with rituximab for these patients,” added Dr Patrick Laroche, Haematology Therapy Area lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. “This new non-chemotherapy combination regimen can offer extended remission as well as fewer chemotherapy-related side effects for patients living with CLL.”
Adverse events for the IR arm were consistent with the known safety profiles for ibrutinib and rituximab, the most common observed with Imbruvica being diarrhoea, neutropenia, musculoskeletal pain, rash, haemorrhage, thrombocytopenia, nausea, pyrexia, arthralgia, and upper respiratory tract infection.
The most common serious side effects (which may affect more than 1 in 20 people) include neutropenia, lymphocytosis, thrombocytopenia, pneumonia and hypertension.