Posted by Michael Wonder on 31 May 2021
Marketing approval received in Japan for Ninlaro as a maintenance therapy after first-line treatment for multiple myeloma without prior stem cell transplantation
27 May 2021 - Takeda today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare for a partial amendment to the manufacturing and marketing approval of Ninlaro (ixazomib citrate) to expand the eligible patient population for this medicine to those requiring a maintenance therapy after first-line treatment for multiple myeloma without prior stem cell transplant.
The approval is based primarily on the results of the TOURMALINE-MM4 study, a randomized and placebo-controlled double-blind multi-centre international Phase 3 clinical trial.
