2019 New Drug Approvals: Hematology
Visit our New Drug Products page to stay up-to-date on the latest hematology drug approvals.
Multiple Myeloma
2019 New Drug Approvals: Hematology/Oncology
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Novel Therapy Treats Triple-Class Refractory Multiple Myeloma
Partial response or better observed in 26 percent of patients receiving oral selinexor-dexamethasone
Isatuximab to Get FDA Review for Relapsed/Refractory Multiple Myeloma
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).
FDA Approves Novel Therapy for Relapsed, Refractory Multiple Myeloma
Continued approval of Xpovio for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Darzalex Gets Approval for Additional Multiple Myeloma Indication
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.
Cardiovascular AEs Common With Carfilzomib in Multiple Myeloma
Patients with relapsed multiple myeloma experiencing CVAEs had inferior survival.
Recommendations Issued for Imaging Use in Multiple Myeloma
Low-dose whole-body CT recommended over conventional skeletal survey for detection of bone disease
FDA Approves New Administration Option for Darzalex
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.
FDA Approves Additional Multiple Myeloma Indication for Empliciti
Approval was based on results from ELOQUENT-3, a Phase 2, open-label trial (N=117) involving patients with relapsed or refractory multiple myeloma.
