November 27th 2024
LBS-007, a novel targeted therapy, has received FDA fast track designation for the treatment of acute myeloid leukemia.
November 25th 2024
November 15th 2024
November 14th 2024
November 12th 2024
Narsoplimab Shows Promise in Treating Posttransplant Complications
February 23rd 2020Evolving data about possible therapeutic targets for the treatment of transplant-associated thrombotic microangiopathy may introduce narsoplimab as a new therapy for management of patients with this challenging complication.
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Evaluation of an expansion cohort of the pivotal phase I/II ZUMA-1 trial in patients with refractory large B-cell lymphoma revealed that early steroid intervention may have a positive impact on the toxicity profile of chimeric antigen receptor T-cell therapy with axicabtagene ciloleucel, according to findings presented during a poster session at the 2020 Transplantation & Cellular Therapy Meetings in Orlando, Florida.
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Favorable Safety and Efficacy May Be Possible With Off-the-Shelf CAR T Cells in NHL
February 22nd 2020Use of an off-the-shelf chimeric antigen receptor T-cell product may be feasible for use in patients with relapsed/refractory B-cell malignancies for whom no other available therapies exist, according to results of a phase I trial in adult and pediatric patients that were presented at the 2020 Transplant & Cellular Therapies Meeting in Orlando, Florida.
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Conditioning Therapy With Iomab-B Improves Transplant Outcomes in Active AML
February 21st 2020Preliminary results of the phase III SIERRA trial indicate that conditioning therapy with iodine apamistamab leads to high rates of allogeneic hematopoietic stem cell transplant in patients with active acute myeloid leukemia, according to Boglarka Gyurkocza, MD, who presented midpoint results of the trial at the 2020 Transplant & Cellular Therapies Meeting in Orlando, Florida.
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Ruxolitinib Observed To Be Safe, Effective for Treating Chronic GVHD in Different Patient Subsets
February 20th 2020Treating chronic graft-versus-host disease with ruxolitinib in both adult and pediatric patients was found to be safe and effective based on data from 2 separate single-center retrospective analyses whose results were presented during a poster session at the 2020 Transplantation & Cellular Therapy Meetings in Orlando, Florida.
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CLR 131 Elicits Notable Responses in Select Relapsed/Refractory B-cell Malignancies
February 20th 2020In the phase II CLOVER-1 trial, the small-molecule phospholipid drug conjugate CLR 131, achieved high response rates in patients with relapsed/refractory multiple myeloma and relapsed/refractory non-Hodgkin lymphoma, meeting the primary efficacy end point of the study, according to a press release from Cellectar Biosciences, developer of the agent.
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SIERRA Trial: Background on the Iomab-B Combination in Relapsed/Refractory AML
February 19th 2020In an interview with <em>Targeted Oncology</em>, Rajneesh Nath, MD, discussed the background and rationale for the phase III SIERRA trial. He also explained what this research means for the treatment landscape of acute myeloid leukemia.
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Bruton Tyrosine Kinase Inhibitors Signal Promise in the Treatment of Chronic Lymphocytic Leukemia
February 18th 2020The use of agents targeting Bruton tyrosine kinase have moved into the standard of care for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma in recent years. New data have indicated that more effective therapy by way of combination regimens and newly approved agents may further improve the prognosis of this disease.
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FDA Grants Priority Review to Tazemetostat in Relapsed/Refractory Follicular Lymphoma
February 14th 2020The FDA has granted Priority Review to the New Drug Application for tazemetostat as treatment for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy. The drug will now be considered for accelerated approval and the application was designation as a supplemental NDA with a Prescription Drug User Fee Act target action date of June 18, 2020, Epizyme, Inc announced in a press release.
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FDA Grant Priority Review to Liso-cel In Relapsed/Refractory Large B-cell Lymphoma
February 13th 2020The FDA has granted Priority Review to the Biologics License Application for lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, after at least 2 prior therapies.
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Advances and Setbacks With Precision Medicine in Hodgkin Lymphoma, T-Cell Lymphomas
February 12th 2020In an interview with Targeted Oncology, Allison J. Moskowitz, MD, discussed the treatment options for patients with Hodgkin lymphoma and what research is still to come in the field. She also compared the treatment landscape of Hodgkin lymphoma with that of T-cell lymphomas, a rare subset of patients.
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Alisertib and Romidepsin Combination Remains Safe in Relapsed/Refractory Lymphomas
February 12th 2020The aurora A kinase inhibitor alisertib plus the class I histone deacetylase inhibitor romidepsin is a safe combination for the treatment of patients with relapsed/refractory lymphomas, according to the findings from a phase I study whose results were published by Paolo Strati, MD, and colleagues in Haematologica.
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Evaluating the Role of CAR T-Cell Therapy in Relapsed/Refractory DLBCL
February 12th 2020Karl M. Kilgore, PhD, discusses the role of chimeric antigen receptor T-cell therapy as treatment of patients with relapsed/refractory diffuse large B-cell lymphoma and where this option might fit into the landscape in the future.
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Predictive Value of Select Gene Mutations Demonstrated in Phase III CLL Study
February 11th 2020Next-generation sequencing in patients with chronic lymphocytic leukemia treated with the combination of chlorambucil and ofatumumab showed that the presence of TP53, SF3B1, and NOTCH1 mutations were predictive of reduced efficacy, according to the results of the phase III COMPLEMENT1 trial published in Haematologica.
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A Look Back at FDA News from January 2020
February 8th 2020In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.
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Gemtuzumab Added to Induction Therapy Shows Limited EFS Benefit in NPM1-Mutant AML
January 31st 2020Following the FDA approval of gemtuzumab ozogamicin with induction and consolidation therapy in newly diagnosed CD33-positive acute myeloid leukemia, investigators led by Richard F. Schlenk, MD, hypothesized that patients with NPM1-mutated acute myeloid leukemia, which occurs in 20% to 30% of the patient population, could also derive benefit from gemtuzumab.
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Novel Triplet Regimen Induces Promising Early Activity in Relapsed/Refractory CLL
January 31st 2020In an interview with Targeted Oncology, Paul M. Barr, MD, discussed the rationale and preliminary findings for the phase I/II study evaluating umbralisib and ublituximab plus venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia. He also explained how the role of combination therapy continues to evolve in this space.
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