TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 208462, 2015)
Takeda Pharmaceutical Company Limited · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA granted priority review to Takeda's Ninlaro (ixazomib) capsules for relapsed/refractory multiple myeloma. Based on a Phase 3 trial, the drug demonstrated improved progression-free survival. The review details Ninlaro's efficacy and safety profile, including common adverse events and specific warnings.
Key findings — cited to the page
| Review type | priority review | NINLARO (ixazomib) · p.3 |
| Trial design | double-blind, randomized controlled trial | A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 plus Lenalidomide and Dexamethasone Versus Placebo plus Lenalidomide and Dexamethasone in Adult Patients with Relapsed and/or Refractory Multiple Myeloma · p.3 |
| Number of patients randomized | 722 | · p.7 |
| Progression-free survival (PFS) | 20.6 months | · p.7 |
| Peripheral neuropathy (ixazomib arm) | 38.9 % | · p.7 |
| PFS (placebo arm, final analysis) | 15.9 months | · p.8 |
| Peripheral neuropathy (placebo arm) | 31.1 % | · p.7 |
| Eye disorders (ixazomib arm) | 26.4 % | · p.7 |
| Eye disorders (placebo arm) | 15.8 % | · p.7 |
| Hepatotoxicity (ixazomib arm, severe drug-related events) | 2.2 % | · p.7 |
| Hepatotoxicity (placebo arm, severe drug-related events) | 0 % | · p.7 |
| NDA submission date | July 10, 2015 | NINLARO (ixazomib) · p.3 |
Source: Takeda Pharmaceutical Company Limited ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →