An issue that the FDA had with the results was that while only
10% of patients had their largest melanoma lesion less than 1cm2
in size, these patients contributed to 30% of the overall durable
response.
There was also limited evidence of a systemic effect with T-Vec,
with the effect on subclinical micrometastases in question if there
is limited systemic action.
Safety Issues
There were several safety issues linked to T-Vec. In the T-Vec arm,
25.7% of patients experienced serious adverse events (with 13.4%
serious adverse events in the control arm). One patient receiving
T-Vec required a limb amputation, with T-Vec treatment being linked
to the outcome. And the issue of herpes virus shedding and possible
infection of healthcare workers was cited as a potential risk
with the treatment. Amgen has proposed a pharmacovigilance plan.
Re the systemic effect: I understand this is where Cavatak shines.
It results in distant tumours being able to be treated via simple intravenous injection (of Cavatak).
And the relative safety issues!!!!
The report says it all!
VLA Price at posting:
44.5¢ Sentiment: Buy Disclosure: Held
