Xencor Earns Milestone Payment from MorphoSys for FDA Approval of Monjuvi® (tafasitamab-cxix) in the United States PRESS RELEASE Businesswire Aug. 1, 2020, 04:49 AM The median duration of response was 21.7 months. Be the first to rate this post.
Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. The U.S. Food and Drug Administration (FDA) has granted priority review to MorphoSys’ application seeking approval of its CD19 antibody tafasitamab, in combination with Revlimid (lenalidomide), to treat people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).. The FDA has 60 days to determine whether the application is complete and acceptable for filing.“The BLA submission marks a significant milestone in MorphoSys’ history and demonstrates our dedication to address the high medical need in relapsed or refractory DLBCL,” Malte Peters, MD, chief development officer of MorphoSys, said in a Tafasitamab (formerly known as MOR208) is an antibody that targets a protein called The ongoing L-MIND clinical trial is testing tafasitamab, in combination with Revlimid, as a treatment for DLBCL patients who are unfit for high-dose chemotherapy and The study’s main goal was to determine the proportion of patients responding, partially or completely, to the combination.
The FDA has granted Priority Review to the newly accepted Biologics License Application for tafasitamab and lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The most common serious or worse treatment-emergent adverse events were low levels of neutrophils (a type of immune cell), low platelet counts, and anemia. Secondary measures included assessing those with at least stable disease, duration of response, time to disease progression or death, overall survival, and safety.This update included data from all 80 patients in the trial, who had been followed for at least one year.
A total of 81 patients with previously treated DLBCL received tafasitamab plus lenalidomide for a maximum of 12 cycles, followed by tafasitamab maintenance.The treatment led to an ORR of 55%, including complete responses in 37% of patients. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.Lymphoma News Today is strictly a news and information website about the disease. After examining specific qualification criteria such as age, gender, and number of prior therapies, researchers ended up with a subset of 76 patients, matched for 76 of the 80 L-MIND patients.The addition of tafasitamab also tripled complete responses (39.5% vs. 11.8%) and reduced the risk of disease worsening or death by 53%.“I’m very excited about this real-world data approach of the Re-MIND trial to isolate a single-agent contribution of tafasitamab in combination with lenalidomide in a matched patient population in r/r DLBCL,” Pier Luigi Zinzani, MD, PhD, one of the lead investigators in Re-MIND, said in another No votes so far! Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. The FDA has granted accelerated approval to tafasitamab-cxix in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for autologous hematopoietic cell transplantation (AHCT).
Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email PLANEGG & MUNICH, GERMANY / ACCESSWIRE / July 31, 2020 / MorphoSys AG (FSE:MOR)(Prime Standard Segment; MDAX & TecDAX)(NASDAQ:MOR) today announces that the U.S. Food and Drug Administration (FDA) has approved Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell … The one-year “The results from the L-MIND study … are very encouraging. It does not provide medical advice, diagnosis or treatment. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not …
A CD19-targeted cytolytic antibody, tafasitamab has approval for use in combination with lenalidomide (Revlimid) in adults who are not eligible for autologous stem-cell transplantation. Reductions in Revlimid doses were required in 43% of patients.Aiming to compare L-MIND findings to those of Revlimid treatment alone, researchers designed Re-MIND, a retrospective observational study that included data from matched patients receiving Revlimid in Europe and the U.S. in a real-world clinical setting.Re-MIND collected data from 490 relapsed or refractory DLBCL patients, who were also unfit for stem cell transplant. The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant.