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Celgene: Pomalyst Gets Breakthrough Therapy Designation From FDA

Celgene Corp. (CELG) said Monday that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus or HIV-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV-negative Kaposi's sarcoma.

Kaposi sarcoma is a multi-centric tumor caused by Kaposi sarcoma-associated herpesvirus, also called human herpesvirus-8. Patients suffer multiple lesions on the skin and oral mucosa, or on organs such as the lungs or gastrointestinal mucosa. Kaposi sarcoma most commonly arises in persons infected with HIV.

Celegene noted that while the use of combination anti-retroviral treatments such as cART or HAART has reduced the incidence of advanced Kaposi sarcoma in the U.S., there are still nearly 2,000 new cases each year.

The disease is more highly prevalent in areas of the world where HIV treatments are less available, such as sub-Saharan Africa, and in some countries is the most common tumor in men overall.

"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," said Jay Backstrom, Chief Medical Officer for Celgene.

The FDA granted that Breakthrough Therapy designation on the basis of the results of a clinical study performed under a Cooperative Research and Development Agreement or CRADA by a team led by Dr. Robert Yarchoan, of the HIV and AIDS Malignancy Branch within the Center for Cancer Research of the National Cancer Institutes (NCI).

The results of that study, evaluated Pomalyst in patients with Kaposi sarcoma, with or without HIV infection, many of whom had received prior cytotoxic chemotherapy. The results were published in the Journal of Clinical Oncology.

Celgene said it intends to submit a supplemental New Drug Application for Pomalyst in this disease area by the end of 2019. In addition, the company has two additional studies planned in this disease.

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