Drug updated on 4/24/2024
| Dosage Form | Capsule (oral; 1 mg, 2 mg, 3 mg, 4 mg) |
| Drug Class | Antineoplastics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- In combination with dexamethasone, indicated for the treatment of adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
- Indicated for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Summary
- Pomalidomide (Pomalyst) combined with dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies and have shown disease progression. It is also used for treating AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy or in patients who are HIV-negative.
- Information was derived from seven systematic reviews/meta-analyses, comparing pomalidomide to other treatments based on safety and effectiveness, specifically in the context of relapsed/refractory multiple myeloma.
- Compared to doublet regimens, pomalidomide as part of triplet regimens showed higher overall response rates. However, when matched against other novel treatments like daratumumab and isatuximab-based therapies using network meta-analysis, these options showed better overall response rates than those including Pomalyst.
- An indirect comparison suggested that pomalidomide combined with dexamethasone is effective; however, ixazomib had a significant impact on progression-free survival among several treatments, indicating variable effectiveness depending upon the therapeutic combinations.
- Adverse events associated with pomalidomide varied widely; however, hematologic adverse events such as neutropenia and anemia were particularly noteworthy across studies, suggesting a need for vigilance regarding hematological safety during its use.
- Subgroup analysis revealed that the efficacy of pomalidomide seemed pronounced in subpopulations previously treated with lenalidomide, hinting at its role in overcoming lenalidomide resistance.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pomalyst (pomalidomide) Prescribing Information. | 2021 | Celgene Corporation Summit, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Clinical practice guideline: multiple myeloma. | 2022 | Myeloma Australia |
| Multiple Myeloma, Version 3.2021, NCCN Clinical Practice Guidelines in Oncology. | 2020 | Journal of the National Comprehensive Cancer Network |
| Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. | 2019 | Journal of Clinical Oncology |
| AIDS-Related Kaposi Sarcoma, Version 2.2019. | 2019 | Journal of the National Comprehensive Cancer Network |
| Clinical practice guideline: multiple myeloma. | 2019 | Myeloma Australia |