October 25th 2024
Zanubrutinib, obinutuzumab, and venetoclax delivered promising response and survival data for the treatment of patients with mantle cell lymphoma harboring a TP53 mutation.
September 18th 2024
September 16th 2024
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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Anti-CD20 Agent Yields High Responses in Follicular Lymphoma
January 22nd 2020Rajat Bannerji, MD, PhD, discusses the safety and efficacy results of REGN1979 in the follicular lymphoma cohort enrolled in the phase I study of patients with relapsed/refractory B-Cell non-Hodgkin lymphoma who were previously treated with an anti-CD20 agent.
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Phase Ib Clinical Trial Enrolling to Evaluate Tafasitamab in Treatment-Naive DLBCL
January 18th 2020In an interview with Targeted Oncology, John M. Burke, MD, discussed the ongoing phase Ib First-MIND clinical trial of tafasitamab in combination with R-CHOP with or without lenalidomide as treatment of patients with newly diagnosed diffuse large B-cell lymphoma.
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Umbralisib Developer Seeks FDA Approval In Marginal Zone Lymphoma and Follicular Lymphoma
January 17th 2020A rolling submission of a New Drug Application for umbralisib has been initiated by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. The company reported in a press release that one application was considered to be acceptable for both drugs and the NDA will be completed in the first half of 2020.<br />
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Investigational Bispecific Antibody Signals Safety and Efficacy in B-Cell NHL
January 14th 2020In an interview with Targeted Oncology, Rajat Bannerji, MD, PhD, discussed the safety and efficacy findings from the phase I trial of a bispecific antibody in patients with heavily pretreated NHL, including cohorts of patients with follicular lymphoma and diffuse large B-cell lymphoma.
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Loncastuximab Tesirine Continues to Improve ORR in Relapsed or Refractory DLBCL
January 9th 2020An update to the phase II study of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma showed promising overall response rate, according to a press release from ADC Therapeutics SA.
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FDA Halts Lacutamab Phase II Trial in Advanced T-cell Lymphomas
January 9th 2020The phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas, has been placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent in December of 2019, according to a press release from Innate Pharma SA.
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FDA Grants Orphan Drug Designation to CLR 131 for Treatment of Lymphoplasmacytic Lymphoma
January 6th 2020CLR 131, a small-molecule, targeted Phospholipid Drug Conjugate, has been granted Orphan Drug Designation by the FDA for the treatment of patients with lymphoplasmacytic lymphoma, according to a press release from Cellectar BioSciences, Inc, developer of the drug.<br />
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FDA Approval Sought for Selinexor for Treatment of Patients With Relapsed or Refractory DLBCL
December 23rd 2019A new drug application for selinexor has been submitted to the FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma who have had at least 2 prior multi-drug therapies,and who are ineligible for stem cell transplantation, including chimeric antigen receptor T-cell therapy, according to a press release from Karypharm Therapeutics, developer of selinexor.<br />
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BLA Submitted for Liso-Cel Therapy in Patients With Large B-cell Lymphoma
December 19th 2019A Biologic License Application has been submitted for isocabtagene maraleucel, a chimeric antigen receptor T-cell agent, as a treatment for adult patients with relapsed or refractory large B-cell lymphoma after a minimum of 2 prior therapies, Bristol-Myers Squibb, the manufacturer, reported in a press release.
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Hematology Experts Review Impactful Data from 2019 ASH Annual Meeting
December 13th 2019Following the 2019 ASH Annual Meeting, Targeted Oncology spoke with experts from various specialties in hematology. The experts highlighted some of the top abstracts from the meeting that will impact the way multiple myeloma, leukemias, MPNs, and lymphomas are treated.
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Across Subtypes of B-cell NHL, REGN1979 Produces Promising Responses
December 11th 2019Heavily pretreated patients with relapsed/refractory B-cell non-Hodgkin lymphoma demonstrated antitumor activity when treated with varying dose levels of the human IgG4-based anti-CD20 × anti-CD3 bispecific monoclonalantibody, REGN1979.
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Higher Response Elicited With Initial Higher-Dose Duvelisib in Patients With R/R PTCL
December 9th 2019The administration of a higher initial dose of duvelisib at 75 mg BID led to a higher overall response rate of 62% compared with 40% in patients with relapsed/refractory peripheral T-cell lymphoma who received 25 mg BID, according to data from the dose-optimization phase of the PRIMO trial presented at the 2019 American Society of Hematology Annual Meeting.<br />
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In the final analysis of the GADOLIN study in patients with rituximab-refractory indolent non-Hodgkin lymphoma, the combination of obinutuzumab plus bendamustine reduced the risk of progression or death by 43% compared with bendamustine alone. In patients with follicular lymphoma, the reduction was 49%.
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Lenalidomide/Obinutuzumab Elicits 100% ORR in Rituximab-Refractory Indolent Non-Hodgkin Lymphoma
December 9th 2019A 100% overall response rate was achieved with the combination of lenalidomide and obinutuzumab in patients with relapsed indolent non-Hodgkin lymphoma that was refractory to rituximab, according to findings of a single-arm, phase I/II trial presented at the 2019 American Society of Hematology Annual Meeting and Exposition.<br />
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Findings from a subgroup analysis of the phase III AUGMENT trial of patients aged 70 or older with indolent non-Hodgkin lymphoma showed a 34% reduction in the risk of disease progression or death compared with rituximab plus placebo, according data presented at the 2019 American Society of Hematology Annual Meeting and Exposition.<br />
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Three-Year Overall Survival Data Reported for Axi-Cel in B-Cell Lymphoma
December 8th 2019Patients with refractory large B-cell lymphoma who were treated with Axi-cel had a 3-year overall survival rate of 47%, according to an updated analysis of the phase II ZUMA-1 trial.
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Durable Complete Remissions Achieved in NHL Following CAR T
December 8th 2019Complete remissions were achieved in greater than 20% of patients with highly refractory non-Hodgkin lymphomas who had been previously been treated with chimeric antigen receptor T-cell therapy with Mosunetuzumab, a novel bispecific antibody, according to study results presented at the 2019 American Society of Hematology Annual Meeting.
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Contemporary Therapy for Advanced- Stage Hodgkin Lymphoma
December 6th 2019Hodgkin lymphoma represents approximately 10% of all cases of malignant lymphoma. This group of diseases most commonly affects adolescent and young adults, although approximately 20% to 25% of patients are aged ≥60 years at diagnosis.
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Brentuximab Vedotin Adds Benefit to A+AVD Therapy in cHL
December 3rd 2019Andrew M. Evens, DO, MSc, discusses the significance of the results from the phase III ECHELON-1 trial in which patients with stage III/IV classical Hodgkin lymphoma were treated with the combination of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine.
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A Look Back at FDA News from November 2019
December 2nd 2019In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.
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Contemporary Therapy for Advanced-Stage Hodgkin Lymphoma
November 27th 2019Hodgkin lymphoma represents approximately 10% of all cases of malignant lymphoma. This group of diseases most commonly affects adolescent and young adults, although approximately 20% to 25% of patients are aged ≥60 years at diagnosis. Advanced-stage disease is generally classified as Ann Arbor stage III to IV, but clinical trials often incorporate patients with high-risk stage II disease, such as those with B symptoms, multiple sites, or bulky disease
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