Yervoy (ipilimumab) melanoma immune-based therapy at FDA Feb 9, 2011
Activatng the immune system is a relatively new model for attacking cancer, but it appears to be coming of age. While "true breakthrough" is a term rarely applied in most treatments, ipilimumab (proposed brand-Yervoy) may be just that for patients with melanoma.
As with all new therapies, we need to learn some new terms, but suffice to say that Yervoy activates the immune system. The precise way that it works is on cytotoxic T Lymphocyte associated antigen-4 (CTLA-4) so that the body can have a much more active cancer response. One of the horrible things that some cancers do is to "hide" by blocking some of the ways that the body might fight it. Yervoy tells the body to attack a very aggressive form of skin cancer called melanoma. You may remember some early information on this from the ASCO (American Society of Clinical Oncology) meeting this past summer in Chicago.
The FDA white oak campus (Silver Spring, Maryland) will be the site of the Oncologic Drugs Advisory committee meeting at 8 AM on February 9th, 2011. The meeting materials are already posted at fda.gov and background material is usually available no less than 2 business days before the meeting. This is such a novel drug with some important benefit to risk considerations and potential side effects and it is something to be clearly understood. Current clinical trials involving this new medicine are available atwww.clinicaltrials.gov.
I espect that Yervoy will emerge as a standard of care in melanoma and will most often be used in combination with other medicines or will be sequenced (Yervoy first to activate the immune system) and perhaps followed by other "chemo" to make certain the entire population of melanoma cells are killed. The FDA will have the opportunity to change the course of melanoma treatment.
Yervoy appears to be a cannon in the melanoma arsenal, where previously all we have been using was a very weak bow and a few blunt arrows.