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Partial response or better observed in 26 percent of patients receiving oral selinexor-dexamethasone
A Biologics License Application for an investigational treatment for relapsed/refractory multiple myeloma has been accepted for review by the Food and Drug Administration (FDA).
Continued approval of Xpovio for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The FDA has expanded the approval of Darzalex (daratumumab; Janssen Biotech) to include use in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Patients with relapsed multiple myeloma experiencing CVAEs had inferior survival.
Low-dose whole-body CT recommended over conventional skeletal survey for detection of bone disease
The Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex (daratumumab; Janssen), which provides clinicians the option of splitting the first infusion of daratumumab over 2 consecutive days.
Approval was based on results from ELOQUENT-3, a Phase 2, open-label trial (N=117) involving patients with relapsed or refractory multiple myeloma.