FDA OKs expanded access program for advanced PCa therapy

July 8, 2005

Abbott Laboratories has been granted permission by the FDA to initiate an expanded access program for the investigational agent astrasentan (Xinlay) for men with late-stage, hormone refractory prostate cancer.

Abbott Laboratories has been granted permission by the FDA to initiate an expanded access program for the investigational agent astrasentan (Xinlay) for men with late-stage, hormone refractory prostate cancer. The program is designed to make the therapy available at the earliest opportunity to treat patients with a serious disease for which no comparable alternative therapy or drug is available.

Atrasentan is an oral, once-daily, non-hormonal, non-chemotherapy agent that belongs to a class of compounds known as selective endothelin-A receptor antagonists. Agents in this class antagonize the effect of endothelin-1, a protein thought to be involved in the stimulation of metastasis. A new drug application for astrasentan is under FDA review and contains clinical data regarding disease progression and delay to onset of bone pain.