MULTIPLE MYELOMA

Novel radiotherapeutic CLR 131 has been granted a fast track designation from the FDA as a fourth-line or later treatment for patients with relapsed or refractory multiple myeloma.

The FDA has granted P-BCMA-101 with an orphan drug designation for the treatment of patients with relapsed and/or refractory multiple myeloma.

Patient-reported outcomes from the phase III myeloma X trial suggested that although patients with relapsed multiple myeloma who received salvage autologous stem cell transplantation had an initial reduction in quality of life and experienced a greater impact of adverse events, they had better long-term outcomes compared with patients who received nontransplantation consolidation.

Daratumumab salvage therapy demonstrated a 1-year overall survival rate of 90.9% in patients with multiple myeloma who relapsed following allogeneic stem cell transplantation and also failed several posttransplant therapies, according to findings presented at the 2019 European Society for Blood and Marrow Transplantation Annual Meeting.

Saad Z. Usmani, MD, FACP, chief of Plasma Cell Disorder, director of Clinical Research in Hematologic Malignancies, Levine Cancer Institute, Atrium Health, discusses how to manage early relapse in multiple myeloma.

During a <em>Targeted Oncology </em>live case-based peer perspectives program, Christopher Maisel, MD, recently discussed the treatment options and considerations he makes when treating patients with multiple myeloma.

A look back at all the&nbsp;FDA news&nbsp;that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, and more.

Asymptomatic Relapsed Multiple Myeloma

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&nbsp;all clinical trials examining venetoclax in multiple myeloma,&nbsp;according to AbbVie, co-developer of the BCL-2 inhibitor with Genentech. This hold, placed by the FDA,&nbsp;halts enrollment of new patients on the studies.

Following a recommendation from the&nbsp;Oncologic Drugs Advisory Committee against the accelerated approval of&nbsp;selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added&nbsp;3 months to the review period for the new drug application,&nbsp;making the new action date July 6, 2019.