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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER