With KRAS break­through on the hori­zon, Am­gen's David Reese re­flects on so­tora­si­b's loom­ing re­view date and murky fu­ture

Af­ter decades of fail­ures laid waste to R&D out­fits look­ing to solve the KRAS G12C puz­zle, Am­gen is as close as any­one ever has been to an ap­proval with so­tora­sib. For Am­gen R&D head David Reese, the drug’s loom­ing re­view date is a point of re­flec­tion for his own ca­reer and a big mile­stone for Am­gen’s bloom­ing — if con­tro­ver­sial — next-gen on­col­o­gy pipeline.

Am­gen filed its FDA ap­pli­ca­tion for so­tora­sib in De­cem­ber to treat metasta­t­ic non-small cell lung can­cer with the KRAS mu­ta­tion — once thought to be “un­drug­gable” — months af­ter the agency of­fered its break­through des­ig­na­tion based on piv­otal Phase I da­ta show­ing pre­vi­ous­ly un­heard of re­sponse rates.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA