Takeda Receives FDA Approval for Ninlaro Maintenance in Transplant-Ineligible Myeloma

Takeda today announced that the FDA has approved Ninlaro (ixazomib) as maintenance therapy for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation and who have achieved at least a partial response to induction therapy. The approval was based on results from the Phase 3 TOURMALINE-MM4 trial demonstrating a statistically significant improvement in progression-free survival. Ninlaro is the first oral proteasome inhibitor approved for multiple myeloma maintenance in transplant-ineligible patients.