A KRAS drug is like­ly com­ing — fast — as the FDA points Am­gen’s fron­trun­ner to a loom­ing fin­ish line

Am­gen got the on­col­o­gy world ex­cit­ed with a first look at the po­ten­tial for a KRAS drug to end a decades-long road­block in R&D. And while the field has cooled some­what through 2020, the phar­ma gi­ant now has a for­mal com­mit­ment from the FDA to hur­ry it along as re­searchers prep the fin­ish­ing touch­es to their new drug ap­pli­ca­tion.

Am­gen re­port­ed Tues­day morn­ing that the agency has prof­fered its break­through ther­a­py des­ig­na­tion for its KRAS G12C in­hibitor so­tora­sib for ad­vanced cas­es of non-small cell lung can­cer, with plans to file for an ap­proval be­fore the end of the month. Help­ing them along even more, their drug has been ac­cept­ed in­to the FDA’s Re­al-Time On­col­o­gy Re­view pi­lot pro­gram — a not-so-sub­tle en­dorse­ment of Am­gen’s tri­al de­sign that of­fers a road map for de­vel­op­ers to push through to a mar­ket­ing de­ci­sion.

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