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There's also this quote from the medscape article:
"Cabozantinib should not be used for CRPC outside of clinical trials at this point, but the data should prompt referrals for clinical trials such as the phase 3 trials referred to in the paper, as well as institutional trials listed on ClinicalTrial.gov."
David C. Smith needs to cover his #$%$ for potential liability if his statements get misconstrued as off-label usage endorsement, this doesn't mean that doctors won't use Cabo off-label though.
Dr Dave CHA quite well in the last sentence...
"A new study is reporting "unprecedented" results in the treatment of castration-resistant prostate cancer (CRPC) with the new drug cabozantinib ( Cometriq, Exelixis).
Results were published online November 19 in the Journal of Clinical Oncology.
Cabozantinib is an oral inhibitor of multiple receptor tyrosine kinases, including RET, MET, and vascular endothelial growth factor 2 (VEGFR2). It was recently approved by the US Food and Drug Administration for the treatment of medullary thyroid cancer.
Cabozantinib demonstrated "dramatic and rapid effects" on bone scan lesions in a high proportion of patients, the study authors report. These effects are "echoed in other measures of antitumor effect," they add.
Of the patients randomized to cabozantinib, 72% experienced regression in soft tissue lesions, and 68% of evaluable patients showed improvement on bone scan. In addition, there was complete resolution in 12%.
However, lead author David C. Smith, MD, professor of internal medicine and urology at the University of Michigan Medical School in Ann Arbor, said the study should not change clinical practice at this time. "Cabozantinib should not be used for CRPC outside of clinical trials at this point, but the data should prompt referrals for clinical trials such as the phase 3 trials referred to in the paper, as well as institutional trials listed on ClinicalTrial.gov," he said.
"Dosing is still being assessed and the side-effect profile requires that patients be closely monitored to limit major toxicities," Dr. Smith told Medscape Medical News. "I would not recommend off-label use AT THIS TIME (my emphasis)."
But...the times they are a'changin'...
"A new study is reporting "unprecedented" results "
If true it is likely the FDA would reccomend halting the trial at some point prior to the completion and proceed to "GO". Unprecendented is hardly a term that would be used lightly by any Doctor worth his/her salt.
It's worth noting that he's starting off with a 100 mg dose. I think once more 40 mg data comes through with good efficacy but better AE profiles, we might see some official support for off-label usage.
"David C. Smith needs to cover his #$%$ for potential liability if his statements get misconstrued as off-label usage endorsement, this doesn't mean that doctors won't use Cabo off-label though."
No he doesn't have to cover his six, he is a prinicipal investigator reporting on his results. Crap, half the clinics do not even offer Provenge and a third haven't even incorporated Abiraterone a full year after approval. Anticipating widespread off label use is just setting up for another disappointing outcome.
I agree, there isn't likely to be much off-label usage until the COMET trials unblind, my statement about 40 mg results are probably off the mark.
His prescriptive comments wouldn't be included if he were just reporting descriptive results from his trials though. He is giving a measured statement for behavior here, recommending appropriate enrollment into trials but warning against off-label usage. I interpret this as cautiously positive recommendation for the drug, he wants the right people people to enroll in the trials but doesn't want this statement to be misconstrued as a thumbs-up for off-label usage (i.e. have the patients sign off in clinical trials and you can't sue me if you go off and do this on your own and your patient dies).
True. However, with the "unprecidented" response it is almost a moot point. ...Almost. Although, the clinical trials will reach capacity quickly, the results will be immediate, the news from all the various clinical trials will travel fast, off-label use will accelerate even quicker.
Sentiment: Strong Buy
The results of this study were first presented in Feb 2011 at ASCO GU, since then they have been updated two or three times. It does not diminish the significance of the results, but it does explain the muted reaction as this is not new data. The next significant data release I see is the survival analysis fromt the MTC EXAM trial in late 2013 or early 2014. This may well occur some time proximate to the release of topline results for Comet 2. There will be other presentations of various phase 2 results, but the market tends to discount uncontrolled trial data.