The FINANCIAL — Takeda Pharmaceutical Company Limited on May 24 announced that NINLARO capsules (generic name: ixazomib, development code: MLN9708, hereinafter: “NINLARO”) are now available in Japan.
NINLARO is the first oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone, for which Takeda has obtained the New Drug Application Approval for the treatment of patients with relapsed or refractory multiple myeloma.
The approval of the drug is based on safety and efficacy data from TOURMALINE-MM1, a global Phase 3 clinical trial in patients with relapsed or refractory multiple myeloma. The trial demonstrated a statistically significant and clinically meaningful improvement (35%) in the length of progression free survival (PFS) as a primary endpoint by administering NINLARO in combination with lenalidomide and dexamethasone when compared with placebo in combination with lenalidomide and dexamethasone (hazard ratio = 0.74, p = 0.01, median PFS = 20.6 months in the ixazomib group vs. 14.7 months in the control group, median follow-up period = 14.7 months). The results also demonstrated that the all-oral triplet regimen containing NINLARO had a manageable tolerability and safety profile, according to Takeda.
“Patients with multiple myeloma have many unmet medical needs including continuation of treatment, alleviation of adverse drug reactions, and reduction of the burden of hospital visits,” said Tsudoi Miyoshi, Head of Japan Oncology Business Unit of Takeda. “The launch of NINLARO may make the all-oral triplet regimen available to the patients as well as contribute to their unmet medical needs by once-weekly administration demonstrating manageable tolerability.”