while waiting for the paint to dry,
originally posted by: joeflow77 • Feb 19, 2011 11:03 PM
oncologists will be screaming for access to Cabo, NOW! FDA will go out of their way to find a way to expedite trials in multiple indications with endpoints and evaluations designed to end early to provide broad access as soon as possible. XL184 has already been in PhaseIII for years , so any severe adverse effects are well know and minor compared to the benefit. FDA is in a position to deny relief to tens-of-thousands, possibly hundreds-of thousands of cancer patients with any significant delays. FDA can not use the excuse of safety to call for some complicated, lengthy trial.
this is the real deal, an extremely rare moment in cancer therapeutics and the FDA knows it. approval is primarily a formality at this point and any lengthy delays will cause heads to roll at the FDA.
P3 trial I was referring to was MTC trial. CRADA/CTEP funding was unexpected but does reflect excitement generated amongst oncologists; especially those in positions of power. Was thinking more along the lines of off-label usage with or without reimbursement - pleasantly surprised ANY insurance companies are reimbursing. Comments regarding safety had to do with standard chemo whose mechanism of action is toxicity as opposed to targeting specific mutations and signaling pathways in cancer cells. It appears cabo dosing has been adjusted to minimize
I've worked with lots of chemo drugs during ~ 30yrs in discovery research (mostly in oncology), - experimental compounds as well as FDA approved. We tested standard chemo on a large collection of cancer cell lines to benchmark activity of our experimental drugs. Resting peripheral blood mononuclear cells (PBMC) were used as some gauge of generalized cytotoxicity that we wanted to avoid. Many standard, FDA-approved drugs were extremely toxic to resting PBMC which was criteria for rejecting any of our experimental compounds. One notably toxic drug that was approved relatively recently was Velcade (bortezomib). Velcade was hailed as a "new" approach to chemo by blocking an organelle known as the proteasome. I believe people died during clinical trials and the side effects were/are severe. In spite of it being advertised as a new therapeutic approach, Velcade is very much a cytotoxic in the vein of traditional chemotherapeutics. As such, I was not concerned about cabo's AEs given the clinical response. Time has only reaffirmed my convictions from 2yrs. ago