The designation has been granted for Pomalyst to treat patients with HIV-positive Kaposi sarcoma who have previously received systemic chemotherapy, in addition to patients with HIV‐negative Kaposi’s sarcoma.
Kaposi sarcoma is a multicentric tumor induced by Kaposi sarcoma-associated herpesvirus, which is also known as human herpesvirus-8. Kaposi sarcoma mostly occurs in persons infected with HIV.
Pomalyst is one of the firm’s IMiD agents and rally-available compounds for the treatment of some blood cancers.
It is a thalidomide analogue indicated, in combination with dexamethasone, to treat patients with multiple myeloma who have received at least two prior therapies including lenalidomide and proteasome inhibitor and have showed disease progression on or within 60 days of completion of the last therapy.
Celgene chief medical officer Dr 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 program forward for patients with this rare and serious cancer.”
FDA has provided the breakthrough therapy status based on the results of a clinical study conducted under a Cooperative Research and Development Agreement (CRADA) by a team headed by Dr. Robert Yarchoan, of the HIV and AIDS Malignancy Branch within the Center for Cancer Research of the National Cancer Institutes (NCI).
The study assessed Pomalyst in patients with Kaposi sarcoma, with or without HIV infection, many of whom had received prior cytotoxic chemotherapy, said the company.
Celgene intends to submit a supplemental New Drug Application for Pomalyst in this disease area by the end of this year. The company is also planning to conduct two additional studies in this disease.
Celgene, in partnership with the AIDS Malignancy Consortium (AMC), will conduct a multicenter study in the US to confirm and expand the results of the NCI study.
The AMC is also sponsoring a second study in sub-Saharan Africa, where Kaposi sarcoma is a major issue.
According to the company, Pomalyst has not yet secured approval for the treatment of Kaposi sarcoma in any country.