Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 2.3 mg, 3 mg, 4 mg) |
Drug Class | Proteasome inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
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Summary
- Ninlaro (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Daratumumab- and isatuximab-based treatments exhibited higher Objective Response Rates (ORRs) compared to ixazomib-based treatments, with ixazomib showing a higher ORR when combined with lenalidomide and dexamethasone (IRd) than with lenalidomide and dexamethasone alone (Rd), bortezomib monotherapy, or dexamethasone.
- Ixazomib-based therapy provided a significant progression-free survival (PFS) benefit in patients with high-risk cytogenetic abnormalities, specifically t(4;14) and amp1q21. Ixazomib maintenance therapy also significantly extended PFS compared to placebo.
- IRd showed significantly longer overall survival (OS) than bortezomib, dexamethasone, and pomalidomide-dexamethasone, with OS comparable to regimens such as Rd, elotuzumab-lenalidomide-dexamethasone (ERd), carfilzomib-lenalidomide-dexamethasone (KRd), and daratumumab-lenalidomide-dexamethasone (DRd).
- Ixazomib maintenance therapy is associated with higher incidences of grade 3-4 thrombocytopenia, neuropathy, grade 3-4 infections, and gastrointestinal disorders, without significant correlation with grade 3-4 neutropenia or new primary malignant tumors.
- Proteasome inhibitor maintenance (PIM) therapy including ixazomib did not show significant differences in the development of secondary primary malignancies or severe peripheral neuropathy compared to control arms.
- The studies focused on patients with high-risk cytogenetic abnormalities (t(4;14) and amp1q21), newly diagnosed multiple myeloma (NDMM), and relapsed/refractory multiple myeloma (RRMM), demonstrating that ixazomib significantly improved progression-free survival (PFS) in high-risk cytogenetic subgroups, particularly in those with t(4;14) and amp1q21 abnormalities, with less effectiveness in NDMM maintenance therapy compared to lenalidomide-carfilzomib, while the IRd regimen in RRMM showed significant benefits in objective response rates (ORR), PFS, and overall survival (OS) relative to other regimens.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ninlaro (ixazomib) Prescribing Information. | 2024 | Takeda Pharmaceutical Company Limited., Cambridge, MA |