Drug updated on 10/31/2024
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.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- In multiple myeloma patients with high-risk cytogenetic abnormalities, ixazomib-based therapy significantly prolonged progression-free survival (PFS), with specific benefits observed in subgroups such as those with t(4;14) (Hazard Ratio (HR) 0.68; median PFS 22.4 vs. 13.2 months) and amp1q21 (HR 0.77; median PFS 18.8 vs. 14.5 months), as indicated in the TOURMALINE trials.
- Meta-analyses revealed that ixazomib maintenance therapy consistently improved PFS across patient populations, with a pooled hazard ratio of 0.69 (95% CI: 0.59-0.79), though high-risk cytogenetic patients had less marked benefits (HR 0.74; 95% CI (confidence interval): 0.47-1.00), and ixazomib showed a significant overall survival (OS) benefit compared to placebo, with odds ratios ranging from 1.36 to 2.05.
- Ixazomib-based therapy was associated with significantly increased risks of grade 3-4 thrombocytopenia (RR (relative risk) = 7.47; 95% CI = 2.06-27.06), grade 3-4 infections (RR = 1.77; 95% CI = 1.21-2.59), neuropathy (RR = 1.48; 95% CI = 1.14-1.92), and gastrointestinal disorders (RR = 1.48; 95% CI = 1.32-1.66), with no significant increases observed in grade 3-4 neutropenia (RR = 1.46; 95% CI = 0.77-2.78) or new primary malignancies (RR = 0.88; 95% CI = 0.53-1.46).
- Proteasome inhibitor maintenance (PIM) therapy, including ixazomib, demonstrated no significant increase in secondary primary malignancies (SPM) or grade ≥3 peripheral neuropathy when compared to control groups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ninlaro (ixazomib) Prescribing Information. | 2024 | Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Pan-Canadian Oncology Drug Review Final Clinical Guidance Report: Ixazomib (Ninlaro) for Multiple Myeloma | 2019 | Canadian Agency for Drugs and Technologies |