The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pomalyst (pomalidomide; Celgene) for the treatment of patients with Kaposi sarcoma.
Pomalyst is being investigated as a potential treatment for patients with HIV-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as in those with HIV-negative Kaposi sarcoma. Currently, there are no FDA-approved treatments for HIV-positive Kaposi sarcoma patients who are refractory to or intolerant of systemic chemotherapy.
The Breakthrough Therapy designation was based on data from a clinical study involving 22 patients with Kaposi sarcoma. Results showed that among these patients, Pomalyst was well tolerated and active regardless of HIV status. A supplemental New Drug Application (sNDA) for this indication is expected to be submitted to the FDA by the end of 2019.
Pomalyst, a thalidomide analogue, is currently approved for multiple myeloma, in combination with dexamethasone, in patients who have received at least 2 prior therapies (including lenalidomide and a proteasome inhibitor), and have shown disease progression on or within 60 days of completion of the last therapy.
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