MULTIPLE MYELOMA
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Relapsed/Refractory Multiple Myeloma
A 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.
Be 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.
A 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.
Following 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.
A 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.
Gareth 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.
Sagar Lonial, MD, discussed some of the emerging agents for the treatment of patients with late relapse in multiple myeloma.
Gareth Morgan, MD, discusses where he sees the field headed for the treatment of patients with multiple myeloma.
In 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.
According 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.
In 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.
Nina Shah, MD, discusses the promise of the CAR T-cell therapy bb21217 in the complex treatment paradigm of relapsed/refractory multiple myeloma.
David S. Siegel, MD, PhD, discusses a trial in which patients with multiple myeloma who progressed on lenalidomide were treated with a pomalidomide-based regimen.
Maintenance 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.
Based 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.
<br /> ​Maria-Victoria Mateos, MD, PhD, discusses the key takeaways from the findings from the phase III ALCYONE trial for patients with multiple myeloma.
The 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.
The 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.
A look back at all the FDA news in oncology from the month of January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.
FDA 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.