May 14th 2024
During a Case-Based Roundtable® event, Jonathan L. Kaufman, MD, discussed which lines of therapy and at what doses would be appropriate to use selinexor in a patient with relapsed/refractory multiple myeloma in the second article of a 2-part series.
Community Practice Connections™: Real-World Applications of Novel Therapies Across TNBC and Addressing Disparities in Care
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6th Annual Precision Medicine Symposium: An Illustrated Tumor Board
October 18-19, 2024
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Advances in TNBC: Communicating with Your Patients About Clinical Trial Awareness and Treatment Concerns to Improve Clinical Outcomes
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Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board
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Approval Sought for Frontline Daratumumab Combo in Transplant-Eligible Myeloma
March 26th 2019A supplemental biologics license application has been submitted to the FDA for the potential approval of a new indication for daratumumab. The sBLA was for the combination of daratumumab plus bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.
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FDA Warning Issued for Investigational Venetoclax Use in Myeloma Trials
March 22nd 2019Be careful with the investigational use of venetoclax (Venclexta) for the treatment of patients with multiple myeloma, the FDA has warned in an alert to healthcare professionals and clinical investigators.
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FDA Puts Enrollment Hold on Venetoclax Myeloma Trials
March 19th 2019A partial clinical hold has been placed on all clinical trials examining venetoclax in multiple myeloma, according to AbbVie, co-developer of the BCL-2 inhibitor with Genentech. This hold, placed by the FDA, halts enrollment of new patients on the studies.
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FDA Extends Review of Selinexor Application for Myeloma
March 15th 2019Following a recommendation from the Oncologic Drugs Advisory Committee against the accelerated approval of selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added 3 months to the review period for the new drug application, making the new action date July 6, 2019.
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Approval Sought for sBLA of Upfront Daratumumab Combo in Transplant-Ineligible Multiple Myeloma
March 14th 2019A rolling submission has been completed to the FDA for the potential approval of the combination of daratumumab (Darzalex) plus lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
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Maintenance Ixazomib Slows Progression in Myeloma
March 12th 2019Gareth Morgan, MD, PhD, presented the findings for the final analysis from the phase III TOURMALINE-MM3 trial at the 2019 Transplantation and Cellular Therapy Meetings, where there was a 28% reduction in the risk of progression and death in patients with newly diagnosed multiple myeloma.
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FDA Panel Not in Support of Accelerated Approval of Selinexor in Myeloma
February 27th 2019In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee decided against the accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma. Instead, the committee recommended delaying a decision on the NDA until results are available from the pivotal phase III BOSTON trial.
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Phase III Trial Confirms Subcutaneous Daratumumab Noninferior to Standard in Myeloma
February 26th 2019According to findings from the phase III COLUMBA trial in patients with relapsed/refractory multiple myeloma, a subcutaneous formulation of daratumumab is noninferior in terms of inefficacy and pharmacokinetics to the standard intravenous daratumumab.
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Encouraging PFS Data Seen With Maintenance Ixazomib in Multiple Myeloma
February 21st 2019In findings from a final PFS analysis of the phase III TOURMALINE-MM3 trial presented during the 2019 Transplantation and Cellular Therapy Meetings, 2-year maintenance therapy with the oral proteasome inhibitor ixazomib following autologous stem cell transplantation improved progression-free survival in patients with multiple myeloma.
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Lenalidomide Maintenance Improves PFS, OS in Patients With Transplant-Eligible Multiple Myeloma
February 14th 2019Maintenance therapy with lenalidomide (Revlimid) significantly improved progression-free survival compared with observation alone in patients with newly diagnosed multiple myeloma and the benefit was seen in both transplant-eligible and -ineligible groups.
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Split-Dosing of Daratumumab Approved by FDA for Multiple Myeloma
February 13th 2019Based on findings from the phase Ib EQUULEUS (MMY1001) trial, a split-dosing regimen of daratumumab has been approved by the FDA for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session.
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Phase III Isatuximab Trial Meets Primary Endpoint of Improving PFS in Relapsed/Refractory Myeloma
February 11th 2019The phase III ICARIA-MM trial has met its primary endpoint of improving progression-free survival with the combination of pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma compared with pomalidomide and dexamethasone alone.
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FDA's ODAC Set to Review Selinexor Application in Penta-Refractory Myeloma
February 8th 2019The FDA's Oncologic Drugs Advisory Committee will hold a hearing on February 26, 2019, to discuss a new drug application for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.
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Frontline Daratumumab Triplet Seeking FDA Approval in Multiple Myeloma
January 23rd 2019FDA approval is being sought for the combination of daratumumab with lenalidomide and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant. Genmab, which co-develops daratumumab with Janssen Biotech, announced that a supplemental Biologics License Application has been initiated with the FDA.
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