Posted by Michael Wonder on 14 May 2019
Celgene Corporation announces Pomalyst granted breakthrough therapy designation from FDA for HIV positive and negative Kaposi sarcoma
13 May 2019 - Celgene plans to submit sNDA by end of 2019.
Celgene Corporation today announced that the U.S. FDA has granted breakthrough therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma.
The breakthrough therapy designation was granted by the FDA on the basis of the results of a clinical study performed under a Cooperative Research and Development Agreement 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.
