CELG Celgene Corporation

By Michael Dabaie

Celgene Corp. (CELG) said the U.S. Food and Drug Administration granted breakthrough therapy designation to Pomalyst to treat patients with human immunodeficiency virus-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV-negative Kaposi's sarcoma.

Kaposi sarcoma is a multicentric tumor caused by Kaposi sarcoma-associated herpesvirus, also called human herpesvirus-8. Kaposi sarcoma most commonly arises in people infected with HIV.

Celgene plans to submit a supplemental New Drug Application for Pomalyst by the end of this year.

Breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases. The FDA granted the designation based on a clinical study performed 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.

Celgene has two additional studies planned. In partnership with the AIDS Malignancy Consortium, a U.S. multicenter study will be performed. The AMC also is sponsoring a second study in sub-Saharan Africa, where Kaposi sarcoma continues to be a serious problem, the company said.

Celgene shares rose slightly premarket, up 0.1% to $96.45.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

May 13, 2019 08:06 ET (12:06 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.