Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 1 mg, 2 mg, 3 mg, 4 mg) |
| Drug Class | Thalidomide analogues |
| 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).
Latest News
Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Pomalidomide-based combination regimens demonstrated an overall response rate (ORR) of 69.9% in the intention-to-treat (ITT) population, with higher rates in the second-line (2L) population at 87.2%, and complete response (CR) rates of 12.1% and 29.7% for the ITT and 2L populations, respectively. Notably, 2L treatment regimens were significantly more effective than those in later lines (≥2L).
- One-year progression-free survival (PFS) rates for pomalidomide-based combinations were 55.1% in the ITT population and 74.0% in the 2L population, while two-year PFS rates were 29.3% and 41.9%, respectively. Comparatively, pomalidomide-based regimens showed inferior PFS when compared to daratumumab-based regimens.
- Pomalidomide-based regimens reported a high incidence of adverse events (AEs), with neutropenia occurring in 32.1% of patients and cough in 43.3%. These findings highlight the hematologic and non-hematologic AEs associated with the treatment.
- No direct safety comparisons were provided for pomalidomide against other drugs, but the data indicated a need for further studies to address the various adverse events observed across different pomalidomide-based triplet regimens.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pomalyst (pomalidomide) Prescribing Information. | 2023 | Bristol-Myers Squibb, Princeton, 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 |