There's a lot left unsaid here. Should the lack of efficacy data in HER2+ have been used to curtail the pan-tumor accelerated approval? Is it really robust enough to know that HER2 directed therapy doesn't work in Sarcoma? Does limiting the available armamentarium help patients? Are these tradeoffs the FDA is compelled to evaluate?
There's a lot left unsaid here. Should the lack of efficacy data in HER2+ have been used to curtail the pan-tumor accelerated approval? Is it really robust enough to know that HER2 directed therapy doesn't work in Sarcoma? Does limiting the available armamentarium help patients? Are these tradeoffs the FDA is compelled to evaluate?