
Janssen’s Imbruvica secures label expansion in Europe in chronic lymphocytic leukaemia
pharmafile | September 7, 2020 | News story | Sales and Marketing | Europe, Janssen, imbruvica, pharma
The European Commission (EC) has moved to expand the existing approval of Janssen’s Imbruvica (ibrutinib) in chronic lymphocytic leukaemia (CLL) to include previously untreated adult patients when used in combination with rituximab.
Phase 3 data supplied in support of the application were drawn from 529 previously untreated patients aged 70 years or younger, who were randomised to receive either a standard of care chemo-immunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR), or six cycles of Imbruvica and rituximab followed by Imbruvica until disease progression or unacceptable toxicity is reached.
Patients receiving the Imbruvica/rituximab combo demonstrated a progression-free survival rate of 88% at a median follow-up of 37 months, compared to 75% with the FCR regimen. An advantage in overall survival was also observed in patients receiving the Imbruvica/rituximab combo.
“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 Dr Craig Tendler, Janssen’s Vice President, Clinical Development and Global Medical Affairs, Oncology. “This latest milestone highlights our commitment to studying the full potential of ibrutinib and in developing regimens which can transform what a CLL diagnosis means for patients going forward.”
The ECOG-ACRIN Cancer Research Group was responsible for designing and conducting the study, which was sponsored by the National Cancer Institute.
Matt Fellows
Related Content

LGC Group opens $100M Organic Chemistry Synthesis Centre of Excellence
LGC Group, a life sciences company, has opened its new Organic Chemistry Synthesis Centre of …

Johnson & Johnson announces successful results from trial for myeloma treatment
Global healthcare company, Johnson & Johnson, announced that analysis of its Darzalex (daratumumab) therapy showed …

Bend Bioscience adds commercial spray drying facility to Georgia site
Bend Bioscience has announced the addition of a commercial-scale spray dryer and a Gerteis dry …






