What was the rationale behind using RANO-HGG criteria instead of RAPNO criteria for the primary endpoint in the FIREFLY-1 trial for pLGG?
How will you implement response assessments in patients starting tovorafenib given potential for pseudoprogression vs true progression?
Answer from: at Academic Institution
I think this was a mistake, but I understand that this was requested by the FDA. We all know that MEK and BRAF inhibitors change the pattern of enhancement within days/weeks after the beginning of the treatment. As RANO-HGG is essentially based on the assessment of enhancing measurable and nonmeasur...
The primary endpoint for the FIREFLY-1 trial was the overall response rate using RANO-HGG because, at the time the protocol was designed, this was the only clinically validated response criteria for brain tumors. However, more recently the RAPNO-LGG criteria were published which focuses on T2 weight...