Ferring Pharmaceuticals is having a good month and have gotten two significant Holiday gifts, as do patients with prostate cancer.
Last week, the CHMP announced approval of Ferring Pharmaceutical's new treatment for prostate cancer, Degelarix. Today, the FDA followed suit and approved the first treatment for prostate cancer in many years. This follows some notable efforts by Dendreonwith Provenge and Abbottwith Xinlay to gain approval but not achieve it. Provenge is a biologic immunotherapy while Xinlay was an oral agent of a different class from the injectable Degarelix.
Remarkably, as of this writing, the FDA has a press release out about the approval, but the company does not. Companies can coordinate approval announcements with the FDA, you know. Nor does Ferring issue press releases by RSS Feed. They may be behind in communications, but they are doing something right.
In the category of prostate cancer treatment, there has been no small amount of drama surrounding the Dendreon decision by the FDA. In that case, the FDA's Advisory Committee voted in favor of 17-0 in favor of safety and 13-4 in favor of efficacy, but the agency issued a Complete Response Letter in early May 2007 to the company asking for more studies. Prostate cancer activists have been protesting the FDA's decision since and you would have to be living under a rock not to have heard any of the many missives from the activists.
According to the FDA press release about the new approval, Degarelix is intended to treat patients who have advanced prostate cancer. The compound is part of a class called gonadrotropin releasing hormone (GmRH) receptor inhibitors, which slow the grown and progression of prostate cancer through the suppression of testosterone. While many hormonal treatments may cause an initial surge in testosterone production after injection, the newly approved compound does not have that effect.
This approval is not likely to have any effect on the continuing saga of the efforts to win approval for Provenge. Nor is it likely to assuage the desire of prostate cancer activists who are seeking an immunotherapy that has a far different non-hormonal approach to the treatment of prostate cancer.
Prostate cancer is a disease in which cancer develops in the prostate, a gland in the male reproductive system. It occurs when cells of the prostate mutate and begin to multiply out of control. These cells may spread from the prostate to other parts of the body, especially the bones and lymph nodes.