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Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn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

“Antengene announced it has entered into a global clinical collaboration with MSD to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene

“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The initiation of the pivotal Phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to

“Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at

“EMA approval of the MIRACLE trial protocol is a huge milestone for us. Although we’re already seeing recruitment in our first non-EU country, we believe that this expansion into the EU really supercharges our recruitment potential,” said Walter Klemp, Chairman and CEO of Moleculin. “Importantly, when combined with the sites