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FDA Grants Pomalidomide Breakthrough Designation in Kaposi Sarcoma

Gina Columbus @ginacolumbusonc
Published: Monday, May 13, 2019

Jay Backstrom, MD

Jay Backstrom, MD

The FDA has granted a breakthrough therapy designation to pomalidomide (Pomalyst) for use as a treatment for patients with HIV-positive Kaposi sarcoma who have received prior chemotherapy, as well as patients with HIV-negative Kaposi sarcoma.1

Pomalidomide is currently approved in combination with dexamethasone for patients with multiple myeloma who have received ≥2 prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.


  1. Celgene Corporation Announces POMALYST® Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma. Celgene. Published May 13, 2019. Accessed May 13, 2019.
  2. Polizzotto MN, Uldrick TS, Wykvill KM, et al. Pomalidomide for symptomatic kaposi's sarcoma in people with and without hiv infection: a phase i/ii study. J Clin Oncol. 2016;34(34):4125-4131. doi: 10.1200/JCO.201.

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