A novel treatment for leukemias and lymphomas that arise from immune system T cells, developed by investigators at the Johns Hopkins Kimmel Cancer Center and its Ludwig Center and Lustgarten Laboratory, was found to be effective at killing these cancers in mice bearing human T-cell tumors.
FDA granted accelerated approval to Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA has granted Breakthrough Therapy Designation to Epkinly (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.Â
Researchers at the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital have developed a chimeric antigen receptor (CAR) T-cell therapy targeting T-cell lymphoma, an aggressive and difficult to treat cancer.Â
FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma.Â
The European Commission approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ stage 3 Hodgkin lymphoma.Â
FDA has accepted for priority review the Biologics License Application for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.Â
The Committee for Medicinal Products for Human Use of the European Medicine Agency has adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with doxorubicin, vinblastine, and dacarbazine—or AVD—in adult patients with previously untreated CD30+ stage 3 Hodgkin lymphoma.
The European Medicines Agency has accepted for review the Marketing Authorization Application for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.Â
European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The final European Commission decision on this indication for Tepkinly is anticipated later this year.