Janssen Seeks Approval of a New Indication for IMBRUVICA ® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma

BEERSE, BELGIUM, 8 March 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA® (ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT).Ibrutinib is a once-daily Bruton's tyrosine kinase (BTK) inhibitor that is currently approved for patients with MCL who have received at least one prior line of therapy.[1] MCL is a rare and aggressive type of blood cancer involving the B-lymphocytes, a type of white blood cell. It is currently incurable, with many patients relapsing and requiring multiple lines of subsequent therapy.[2],[3] An unmet need remains for targeted, first-line treatment approaches that can provide disease control over longer periods of time, especially for patients unsuitable for high dose therapy and ASCT.[4],[5]"Mantle cell lymphoma can be a difficult blood cancer to treat, and despite progress in this area over the last few years, an unmet need remains for new treatment approaches,” said Edmond Chan MBChB M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “This submission to the EMA is a testament to our commitment to deepening the impact ibrutinib can have for patients and represents an important step ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news