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Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn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.”

Share:

More News

CEO Snehal Patel commented, “We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a

“At Ferring, we are committed to meeting the unmet needs in bladder cancer care and equipping uro-oncologists with critical evidence they need to deliver effective, and life-changing treatment,” said Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals. “These new

“We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products,” said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. “Both drug targets are well-characterised drivers of many cancers, and we are excited to be

“We do not view today’s unsatisfactory outcome as a failure of Globo H,” Dr. Heidi Wang, CEO of OBI Pharma added. “There may come a time, with a deeper scientific understanding of the Globo H function, it may play a meaningful role once again.”