Celgene’s Pomalyst Secures Breakthrough Designation

Celgene’s Pomalyst (pomalidomide) has been designated a breakthrough therapy for HIV-positive and HIV-negative Kaposi Sarcoma Clinical Trial by the US Food and Drug Administration (FDA).

Pomalyst is an oral thalidomide analogue with multiple mechanisms of action that is a small molecule. It is one of the immunomodulatory imide drug (IMiD) agents that the company is developing as blood cancer treatments.

Patients with multiple myeloma who have already received at least two therapies and have seen disease progression within 60 days are candidates for pomalyst.

Kaposi sarcoma is a multicentric tumor that is brought on by either the human herpesvirus-8 or the Kaposi sarcoma-associated herpesvirus. Multiple lesions on the skin and oral mucosa define it. Other organs, like the lungs and gastrointestinal mucosa, may be affected in some instances.

The tumor is frequently found in HIV-positive individuals. Due to a lack of approved treatments for HIV-positive patients who are refractory to (or intolerant of) systemic chemotherapy, Celgene stated that there is a significant demand for new treatments.

Celgene chief medical officer Jay Backstrom said: “The encouraging news of the FDA breakthrough therapy designation for Pomalyst in Kaposi sarcoma reflects the urgency in accelerating the development of therapies to address diseases of this type.

“We will continue to work closely with the agency to move this programme forward for patients with this rare and serious cancer.”

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