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Epcoritamab-bysp Approved for Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma

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...

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Exploring the Approval of Epcoritamab for Diffuse Large B-Cell Lymphoma With Reid Merryman, MD

In May 2023, the FDA granted approval to epcoritamab, a CD3-redirecting, CD20-targeting bispecific antibody, for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma. Following the approval, Oncology Data Advisor® spoke with Dr. Reid Merryman, an Attending Physician at Dana-Farber Cancer Institute and one of the investigators of the EPCORE NHL-1 trial, on which the approval was based, to learn more about the efficacy and safety of epcoritamab and its burgeoning role in the treatment of relapsed/refractory DLBCL.  

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Exploring the Approval of Epcoritamab for Diffuse Large B-Cell Lymphoma With Reid Merryman, MD

In May 2023, the FDA granted approval to epcoritamab, a CD3-redirecting, CD20-targeting bispecific antibody, for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma. Following the approval, Oncology Data Advisor® spoke with Dr. Reid Merryman, an Attending Physician at Dana-Farber Cancer Institute and one of the investigators of the EPCORE NHL-1 trial, on which the approval was based, to learn more about the efficacy and safety of epcoritamab and its burgeoning role in the treatment of relapsed/refractory DLBCL.  

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Glofitamab-gxbm Approved for Relapsed/Refractory Large B-Cell Lymphomas

The FDA has approved glofitamab-gxbm (Columvi™, Genentech, Inc.) for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma. Patients are required to have undergone two or more previous lines of systemic therapy. Why it matters: "The prognosis is poor for patients who are unsuitable candidates for second-line treatment with aggressive salvage chemotherapy and for those who have received a...

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FDA Approves Loncastuximab Tesirine-lpyl for Relapsed/Refractory Large B-Cell Lymphoma

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...

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Tafasitamab/Lenalidomide for Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Gilles Salles, MD, PhD

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...

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Transplant-Ineligible Diffuse Large B-Cell Lymphoma: Tafasitamab/Lenalidomide Approved

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...

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John Leonard, MD: FDA Approval of Selinexor for DLBCL

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...

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Selinexor Approved for R/R Diffuse Large B-Cell Lymphoma

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...

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B-Cell Malignancies: Treatment Advances in CAR T-Cell Therapy With Stephanie Jackson, MSN, RN, AOCNS®, BMTCN®

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...

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Polatuzumab Vedotin Approved in Relapsed/Refractory DLBCL

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...

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