The FDA has approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified. This approval includes high-grade B-cell lymphoma after two or more lines of systemic therapy and DLBCL arising from indolent lymphoma. Why it matters: "Treatment regimens incorporating anti-CD20 monoclonal antibodies have become the standard of care for DLBCL and follicular lymphoma; however, intrinsic or acquired resistance will occ...
The FDA has granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta™, ADC Therapeutics) for patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, who had two or more lines of systemic therapy. "Loncastuximab tesirine has shown substantial antitumor activity with a manageable toxicity profile in patients with relapsed/refractory DLBC...
Recently, the FDA granted accelerated approval to tafasitamab-cxix (Monjuvi®, MorphoSys US Inc.) in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplantation. In this interview with i3 Health, Gilles Salles, MD, PhD, principal investigator of the phase 2 L-MIND trial, on which the approval was based, discusses the significance of the approval, adverse events of note with tafasitamab/lenal...
The FDA has granted accelerated approval to tafasitamab-cxix (Monjuvi®, MorphoSys US Inc.) in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are ineligible for autologous stem cell transplantation. The approval of tafasitamab, a CD19-directed cytolytic antibody, is based on efficacy data from the single-arm, international phase 2 L-MIND trial (NCT02399085), wh...
Selinexor (Xpovio®, Karyopharm Therapeutics) was recently FDA approved to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This approval extends to patients with DLBCL that resulted from follicular lymphoma and those who had previously received at least two prior lines of systemic therapy. John Leonard, MD, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine, discussed with i3 Health the importance of this approval and the fu...
Accelerated approval was granted to selinexor (Xpovio®, Karyopharm Therapeutics) to treat adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including those with DLBCL resulting from follicular lymphoma, after receiving at least two prior lines of systemic therapy. Selinexor had previously been approved in combination with dexamethasone for adult patients with R/R multiple myeloma who were previously treated with at least four therapies and whose disease is refr...
Outcomes have improved in recent years for patients with B-cell malignancies such as diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia (ALL), but many patients continue to develop relapsed or refractory disease. In this interview with i3 Health, Stephanie Jackson, MSN, RN, AOCNS®, BMTCN®, Oncology Clinical Nurse Specialist at the Ronald Reagan UCLA Medical Center, discusses advances in chimeric antigen receptor (CAR) T-cell therapy, which has been shown to produce significant...
The FDA has now granted accelerated approval to polatuzumab vedotin (Polivy®, Genentech, Inc.) in combination with bendamustine and a rituximab product for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, following two or more prior lines of therapy. Estimates of five-year survival for DLBCL have been reported at 62.0% in the United States and 55.4% in Europe. Over 50% of patients with advanced-stage, previously untreated DLBCL experience complet...