Ninlaro(ixazomib)
Oncology· 373 cited findings· 2 source documents
What the regulatory reviews say
Ninlaro (ixazomib) is a drug indicated for the treatment of multiple myeloma. In a double-blind, randomized controlled trial with 722 patients, the progression-free survival (PFS) in the ixazomib arm was 20.6 months, compared to 14.7 months in the placebo arm (1st interim analysis). The hazard ratio for PFS was 0.74 (P-value: 0.01). The final analysis showed a PFS of 20.0 months in the ixazomib arm and 15.9 months in the placebo arm, with a hazard ratio for PFS of 0.82 (P-value: 0.0548). The overall survival (OS) hazard ratio was 0.900.
Notable safety findings included peripheral neuropathy (38.9% in the ixazomib arm vs. 31.1% in the placebo arm) and eye disorders (26.4% in the ixazomib arm vs. 15.8% in the placebo arm). Severe drug-related hepatotoxicity occurred in 2.2% of patients in the ixazomib arm. Discontinuation due to thrombocytopenia was less than 1% in the NINLARO regimen.
Ninlaro received an Orphan medicinal product designation on 27 September 2011. The NDA submission date was July 10, 2015, and it underwent a priority review, leading to regulatory approval.
Key figures — cited to the source page
| PFS (ixazomib arm, 1st interim analysis) | 20.6 | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.8 |
| PFS (placebo arm, 1st interim analysis) | 14.7 | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.8 |
| Hazard ratio for PFS (1st interim analysis) | 0.74 | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.8 |
| P-value for PFS (1st interim analysis) | 0.01 | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.8 |
| OS HR | 0.900 | Takeda Pharmaceutical Company Limited — Ninlaro EMA EPAR pub, p.124 |
| Peripheral neuropathy (ixazomib arm) | 38.9 | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.7 |
| Peripheral neuropathy (placebo arm) | 31.1 | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.7 |
| Regulatory action | Approval | TAKEDA PHARMS USA — Ninlaro FDA Summary Review (NDA/BLA 2084, p.9 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.