(CercleFinance.com) – The Janssen pharmaceutical companies of Johnson & Johnson announced last night that they are seeking approval from the European Medicines Agency (EMA) for a new indication for Imbruvica (ibrutinib) in combination with the bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplantation (ASCT).
This application is based on the results of a phase 3 study which met its primary endpoint of progression-free survival (PFS).
“This submission to the EMA represents an important step towards providing patients and healthcare professionals with targeted therapy in addition to standard therapy,” the company said.
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