The Japanese Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.'s Ninlaro capsules for the treatment of multiple myeloma, a cancer of plasma cells.
Ninlaro is indicated in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have not responded to standard therapy or who have relapsed after treatment.
The approval is based on a phase 3 trial which demonstrated that the combination treatment increased median progression-free survival by about 6 months or 40% compared to placebo, lenalidomide, and dexamethasone.