March 10th 2023
Soligenix has requested a Type A meeting with the FDA to get clarity around the item needed to complete the new drug application of SGX301 for patients with early-stage cutaneous T-cell lymphoma.
Addition of Bortezomib Shows Efficacy/Safety in Waldenström's MacroglobulinemiaFebruary 15th 2023
A phase 3 trial of bortezomib, dexamethasone, rituximab, and cyclophosphamide shortened the median time to first response and increased the number of patients with Waldenström's macroglobulinemia.
Perez on Real-World Pola-BR Treatment Outcomes in Patients with R/R LBCLJanuary 16th 2023
In an interview with Targeted Oncology, Ariel Perez, MD, explained the outcomes of patients with R/R large B-cell lymphoma who were treated with Pola-BR in the real-world setting, and the key takeaways from a single-institution study.
Samhouri Discusses Practice Changing Data in the DLBCL SpaceJanuary 13th 2023
In an interview with Targeted Oncology, Yazan Samhouri, MD, discussed new agents, clinical trials, and developments creating change in diffuse large B-cell lymphoma, as well as the key takeaways from ASH 2022.
Addition of Polatuzumab to R-CHOP Improves Outcomes for Patients With DLBCLJanuary 10th 2023
In an interview with Targeted Oncology, Gustavo Fonseca, MD, FACP, discussed the positive health-related quality of life findings in patients with diffuse large B-cell lymphoma from the POLARIX study.
FDA Accepts BLA and Grants Priority Review for Glofitamab in R/R LBCLJanuary 6th 2023
Based on data from a phase 1/2 study, a biologics license application has been accepted for glofitimab and the product has been granted priority review to for relapsed/refractory large B-cell lymphoma.
Glofitamab Leads to Durable Complete Remissions in Relapsed/Refractory LBCLJanuary 6th 2023
In an interview with Targeted Oncology, Cyrus M. Khan, MD, further discussed the background of the phase 1/2 trial and the potential use of glofitamab for patients with large B-cell lymphoma in the future.
HD-ASCT Shows Longer Survival Vs Non-Myeloablative Chemoimmunotherapy in Primary CNS LymphomaDecember 13th 2022
An extended progression-free survival and 54% reduction in the risk of death was shown with high-dose chemotherapy autologous stem cell transplantation consolidation therapy vs non-myeloablative chemoimmunotherapy in patients with primary central nervous system lymphoma.
Lenalidomide/ Rituximab Extends 5-Year PFS on R/R Indolent Non-Hodgkin LymphomaDecember 11th 2022
Five-year follow up results from the phase 3 AUGMENT trial show that lenalidomide plus rituximab produced enhanced progression-free survival in patients with relapsed/refractory indolent non-Hodgkin lymphoma.
ECHELON-1 Trial of Brentuximab Vedotin Improves OS in Classical Hodgkin LymphomaDecember 7th 2022
In an interview with Targeted Oncology, David J. Straus, MD, discussed the newest data of the ECHELON-1 trial which he presented at the National Comprehensive Cancer Network 2022 Annual Congress: Hematologic Malignancies.
FDA Grants RMAT and Fast Track Designations to Allogeneic CAR T-Cell Therapy for B-NHLNovember 30th 2022
The allogeneic CAR T-cell therapy CB-010 received regenerative medicine advanced therapy and Fast Track designations for the treatment of patients with B-cell non-Hodgkin lymphoma.
Ultra-Low Dose of Radiation Shows Promise in Orbital Indolent B-Cell LymphomasNovember 28th 2022
In an interview with Targeted Oncology, Chelsea C. Pinnix discussed the results of a phase 2 study and how these promising results will shift the treatment paradigm of patients with orbital indolent B-cell lymphoma.
FDA Grants Priority Review to Subcutaneous Epcoritamab for Previously Treated R/R LBCLNovember 21st 2022
Based on positive findings from the phase 2 pivotal EPCORE NHL-1, the FDA will conduct a speedy review of the biologics license application for subcutaneous epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma after 2 or more lines of systemic therapy an granted it priority review.
FDA Approves Brentuximab Vedotin for Pediatric Patients With High-Risk Hodgkin LymphomaNovember 10th 2022
Based on results from the phase 3 AHOD1331 trial, the FDA has approved brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients with high-risk classical Hodgkin lymphoma.
FDA Advises Against an Approval Filing for Camidanlumab Tesirine to Treat R/R HLNovember 10th 2022
The FDA has advised ADC Therapeutics that a randomized phase 3 confirmatory study is needed to support a future FDA approval for camidanlumab tesirine as treatment of relapsed or refractory Hodgkin lymphoma.