The European Medicines Agency (EMA) has received an application from Johnson & Johnson's Janssen Pharmaceutical Companies for the approval of Imbruvica (ibrutinib) in combination with rituximab as first-line treatment in earlier untreated chronic lymphocytic leukaemia (CLL), it was reported yesterday.
The product is already approved in Europe for CLL as a monotherapy or in combination with obinutuzumab in patients who were earlier untreated for their condition. It is also approved in Europe as a monotherapy or in combination with bendamustine and rituximab for the treatment of the same disease in adults who have undergone around one prior therapy.
It is a Bruton's tyrosine kinase inhibitor that blocks the BTK protein, whose signalling is needed by certain cancer cells to multiply and propagate. Janssen is now seeking further expansion of the drug's label and has therefore submitted a Type II variation application to the regulator based on the findings of phase 3 E1912 trial. The late-stage trial held in the US evaluated 529 patients having earlier untreated CLL, aged 70 years or younger.
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