Beyond the data, this approval is notable for the speed from FDA acceptance of their new drug application (NDA) to FDA approval - just over a month. Compare this to the typical 8-12 month timelines we've historically seen for priority and standard reviews, respectively. This was enabled by the FDA's CNPV Pilot Program [0]

Previous discussion following the data presentation at ASCO: https://news.ycombinator.com/item?id=48517199

[0] https://www.fda.gov/industry/commissioners-national-priority...