Takeda Pharmaceutical Company Limited — Ninlaro EMA EPAR public assessment report (EMEA/H/C/003844, 2016)
Takeda Pharmaceutical Company Limited · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Ninlaro (ixazomib) for multiple myeloma involved a detailed review of its pharmaceutical development, non-clinical pharmacology, pharmacokinetics, and toxicology. Preclinical studies demonstrated proteasome inhibition and anti-tumor activity. Clinical trials, including the pivotal Phase 3 study (C16010), showed a statistically significant improvement in progression-free survival (PFS) for ixazomib in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma patients (median PFS 20.6 vs 14.7 months, HR=0.742). While initial CHMP opinion was negative, re-examination led to conditional marketing authorization. Safety concerns included thrombocytopenia and gastrointestinal events, with ongoing pharmacovigilance. The oral dosing offers patient convenience.
Key findings — cited to the page
| Grade 3 diarrhoea (ixazomib regimen) | 6 % | · p.125 |
| Grade 3 peripheral neuropathy incidence (both regimens) | 2 % | · p.125 |
| all grades of bleeding (ixazomib regimen) | 18 % | · p.125 |
| Grade 3 or higher bleeding (placebo regimen) | <1 % | · p.125 |
| Grade 3 diarrhoea (placebo regimen) | 3 % | · p.125 |
| Grade 3 adverse reactions of peripheral neuropathy (NINLARO regimen) | 2 % | · p.121 |
| Grade 3/4 thrombocytopenia (ixazomib regimen) | 17 % | · p.125 |
| Grade 3/4 thrombocytopenia (placebo regimen) | 8 % | · p.125 |
| all grades of bleeding (placebo regimen) | 16 % | · p.125 |
| Grade 3 or higher bleeding (ixazomib regimen) | 2 % | · p.125 |
| Grade 3 adverse reactions of peripheral neuropathy (placebo regimen) | 2 % | · p.121 |
| Grade 3 adverse reactions of peripheral neuropathy | 2 % | both regimens · p.138 |
Source: Takeda Pharmaceutical Company Limited ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →