Application in European Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn
“We have elected to withdraw our application seeking approval of ibrutinib, in combination with bendamustine and rituximab in first-line mantle cell lymphoma, in the European Union following discussion with the EMA,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “While we are disappointed that this treatment combination will not be available for patients, we will continue our commitment to further understand the potential therapeutic benefit of ibrutinib in the treatment of patients living with mantle cell lymphoma and other haematological malignancies.”
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