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
FDA Grants Fast Track Designation for ME-401 in Relapsed/Refractory FL
April 1st 2020The FDA has granted Fast Track Therapy designation to ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase inhibitor as treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
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Research Builds On Positive ECHELON-1 Study in Hodgkin Lymphoma
March 18th 2020Tatyana Feldman, MD, director of T cell program at the John Theurer Cancer Center, Hackensack Meridian Health, discusses how research is now building upon the positive results from the phase III ECHELON-1 study, which was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.<br />
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Biomarker Impact on Survival in Diffuse Large B-cell Lymphoma
March 12th 2020The largest prospective dataset in previously untreated diffuse large B-cell lymphoma revealed the molecular heterogeneity of diffuse large B-cell lymphoma with potential treatment targets harbored by the cell-of-origin subtypes, based on data from a phase III GOYA study. <br />
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FDA Partially Halts Phase I Study of ACTR707 in Non-Hodgkin Lymphoma
March 12th 2020The FDA has placed a partial clinical hold on the phase I trial of ACTR707 in combination with rituximab in patients with relapsed/refractory B-cell lymphoma from Unum Therapeutics, following the submission of a safety report from the company. The FDA notified Unum of the hold verbally on March 4. Unum Therapeutics acknowledged the partial clinical hold in filings with the Securities and Exchange commission.
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Tazemetostat Combined With R-CHOP Appears Tolerable in Newly Diagnosed DLBCL
March 10th 2020The addition of tazemetostat to rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone was generally well tolerated and demonstrated early anti-tumor activity in patients with newly diagnosed diffuse large B-cell lymphoma, according to the findings from the phase Ib study.
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FDA Grants Orphan Drug Designation to Umbralisib in Follicular Lymphoma
March 6th 2020The FDA granted Orphan Drug Designation to umbralisib, an investigational oral PI3K delta inhibitor as treatment for patients with follicular lymphoma, according to a press release from TG Therapeutics. This designation follows a New Drug Application for treatment of marginal zone lymphoma and follicular lymphoma, which was submitted to the FDA in October 2019, based on results from the phase IIb UNITY-NHL study.
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FDA Fast Track Designation Granted to Tipifarnib for T-Cell Lymphomas
March 3rd 2020The FDA has granted a fast track designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas, according to a press release from Kura Oncology, Inc. The fast track designation includes patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with a T follicular helper phenotype.
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KEYNOTE-204 Meets PFS End Point in Patients With Classical Hodgkin Lymphoma
March 2nd 2020Treatment with pembrolizumab resulted in a statistically and clinically significant improvement in progression-free survival compared with brentuximab vedotin in adults patients with relapsed or refractory classical Hodgkin lymphoma , meeting a dual primary end point of the phase III KEYNOTE-204 trial, according to the interim analysis results announced in press release from Merck.
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FDA Accepts BLA and Grants Priority Review to Tafasitamab/Lenalidomide in R/R DLBCL
March 2nd 2020The FDA has granted Priority Review to the newly accepted Biologics License Application for tafasitamab and lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The Prescription Drug User Fee Act target action date was set as August 30, 2020, with no plans for an advisory committee meeting to discuss the application.
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Careful Data Review Recommended for Upfront Treatment Selection in iNHL
February 29th 2020To enhance outcomes for patients with indolent non-Hodgkin lymphoma, an in-depth review of the available data is required. As a start, Sonali M. Smith, MD, University of Chicago Medicine, reviewed the clinical trial findings that are currently informing treatment selection in the frontline iNHL paradigm, at 24th Annual International Congress on Hematologic Malignancies.
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R-CHOP Still Chosen Over Targeted Therapies in Frontline DLBCL
February 29th 2020In an interview with Targeted Oncology, Jason Westin, MD, MS, FACP, discussed the pros and cons of administering R-CHOP in the frontline setting of diffuse large B-cell lymphoma. He also discussed other options for patients who have limited responses to the standard-of-care.
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Strategic Management of CAR T-cell AEs in Hematologic Malignancies
February 29th 2020For patients receiving chimeric antigen receptor T-cell therapy, cytokine release syndrome and neurotoxicity are the most common toxicities. A multidisciplinary approach to care is vital for these patients, explained Kimberly Noonan, DNP, ANP-BC, AOCN, in a presentation during the 24th Annual International Congress on Hematologic Malignancies.
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Novel Agents Continue to Advance in the Treatment Landscape of DLBCL
February 28th 2020Because diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma in the US, clinical investigators are eager to make progress with novel agents, despite recent advances, said Craig Moskowitz, MD, in a presentation during the 2020 International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma.<br />
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Questioning Future Combinations and Targets for CAR T Cell in DLBCL
February 25th 2020Lori A. Leslie, MD, discusses chimeric antigen receptor T-cell therapy as a treatment for diffuse large B-cell lymphoma and the positive results demonstrated for this agent in patients with relapsed/refractory disease.
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Novel Bispecific Antibody Yields Responses in Aggressive or Indolent NHL
February 25th 2020In an interview with Targeted Oncology, Stephen J. Schuster, MD, discussed the findings for mosunetuzumab in patients with relapsed/refractory non-Hodgkin lymphoma and the particularly promising findings for those patients who had received prior chimeric antigen receptor T-cell therapy.
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Polatuzumab Vedotin Plus Bendamustine/Rituximab Shows Encouraging Activity in R/R DLBCL
February 24th 2020Combining the antibody-drug conjugate polatuzumab vedotin with bendamustine and rituximab resulted in a significantly higher complete response rate in patients with transplantation-ineligible relapsed/refractory diffuse large B-cell lymphoma compared with patients who received BR alone. The international, multicenter, open-label, phase Ib/II trial also found that pola-BR reduced the risk of death by 58%, according to a recent Journal of Clinical Oncology paper.
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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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FDA Grants Priority Review for Selinexor in R/R Diffuse Large B-Cell Lymphoma
February 20th 2020A Priority Review supplemental New Drug Application for selinexor, a selective inhibitor of nuclear export, has been accepted for filing by the FDA, according to the manufacturer, Karyopharm Therapeutics, Inc, in a press release. The application seeks accelerated approval from the agency as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
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CAR T-Cell Therapies Fulfill Unmet Need in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
February 18th 2020In an interview with Targeted Oncology, Jason Westin, MD, discussed findings from a correlative analysis of the cytokine release syndrome and neurotoxicity associated with the chimeric antigen receptor T-cell therapy in the JULIET trial. He highlighted other important takeaways on the data on chimeric antigen receptor cells in diffuse large b-cell lymphoma.
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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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