Pomalidomide

(Pomalyst®)

Pomalyst®

Drug updated on 11/1/2024

Dosage FormCapsule (oral; 1 mg, 2 mg, 3 mg, 4 mg)
Drug ClassAntineoplastics
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).

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Summary
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  • 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 TitleYearSource
Pomalyst (pomalidomide) Prescribing Information.2023Bristol-Myers Squibb, Princeton, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Clinical practice guideline: multiple myeloma.2022Myeloma Australia
Multiple Myeloma, Version 3.2021, NCCN Clinical Practice Guidelines in Oncology.2020Journal of the National Comprehensive Cancer Network
Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline.2019Journal of Clinical Oncology
AIDS-Related Kaposi Sarcoma, Version 2.2019.2019Journal of the National Comprehensive Cancer Network
Clinical practice guideline: multiple myeloma.2019Myeloma Australia