Comet 2 early pain palliation readouts surpass threshholds the FDA benchmarked to issue an SPA? Do we then see the possibility of an NCCN compendium listing for pain palliation in mCPRC? Any thoughts on that? Wouldn't that be a pretty good revenue source in the nearer term? Especially since the study utilized lower dosing, suggesting a modest AE profile?
"Comet 2 early pain palliation readouts surpass threshholds the FDA benchmarked to issue an SPA?"
With no SPA, there are no benchmarks. EXEL needs to complete the trial per protocol and bring the best results possible in order to get the most bang for the buck. If there is one thing that gets negative attention, it is straying from a protocol, just ask Aveo. The only "early results" that would be treated credibly would be from a scheduled interim analysis, and Comet 2 is interim free.
"Do we then see the possibility of an NCCN compendium listing for pain palliation in mCPRC?"
Not likely. If Comet 2 is part of an NDA approval strategy, I do not see the committee stepping on ODAC or FDA turf by trying to be first to approve. More likely is that they will sit back and let the normal approval process proceed.
"Especially since the study utilized lower dosing, suggesting a modest AE profile?"
Modest is a relative term. Even at 60mg, Cabo has a pretty tough toxicity profile with a high rate of dose reductions and grade 2/3's.
There is no magic bullet here. Comet 2 will go to its completion after full enrollment and the off label expectations have not materialized and going forward, EXEL will have to use the normal approval channels. A possibility would be FDA bringing some of the upcoming pivotal trials into its new breakthrough designation. However that status needs to be applied for, and EXEL to date, doesn't seem inclined to move in that direction.
Interesting you mention this - the NCCN just today posted this CME sponsored seminar, scheduled for 7/18/13, and hosted by Azeez Farooki of the Memorial Sloan-Kettering Cancer Center. My suspicion is that you, duckduffer, are not the only one looking at Cabo's potential in addressing bone health...
"NCCN Task Force: Bone Health in Cancer Care :Overview"
"Management of long-term bone health is emerging as a critical aspect of comprehensive cancer care. Bone is the most common site of metastasis and is associated with substantial pain, morbidity, and lower quality of life. Skeletal involvement is associated with increasing rates of fracture, spinal cord compromise, hypercalcemia, and greater need for radiation or surgery. Bone health is severely compromised because of the disease and/or the treatments breast and prostate cancer patients receive. Because bone loss can be asymptomatic before the advent of fractures, it is important that the health care providers are aware of the higher risk of bone disease in this population and understand techniques used to assess both bone loss and bone metastases. The available bone modifying agents have different mechanism of action and adverse effect profiles. Timely interventions and choosing the appropriate bone-modifying agent by carefully weighing risks is critical in the reducing bone-related morbidity. Several novel therapeutic interventions targeting the bone or the bone microenvironment are in development for their ability to affect bone metastases, highlighting the need for improvement in bone health. Clinicians should be aware of novel agents that are in development in order to encourage patient participation in ongoing and upcoming clinical trials "
good find Wilder and Duck....in managing the patient longevity is important ie OS but paramount in my mind also is quality of life....the lower dose Cabo has been shown to minimize AE to those that can be managed effectively...reduced pain and reversal of bone lesions surely must be seen as a benefit to the patient.....for whatever length of time they may have....further as I have said this many times, the best way to deal with cancers is to not get it..(.enter nutrigenomics ie we now have now substantial evidence showing that our diets can turn on and turn off cancer genes) however if we are among the unfortunate ones that become afflicted, quality of life must rate high on the list of priorities.