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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.

References

  1. Celgene Corporation Announces POMALYST® Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma. Celgene. Published May 13, 2019. https://bit.ly/2VgaRGF. 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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