Weeks af­ter drop­ping big re­sponse da­ta, Am­gen lines up pri­or­i­ty re­view for KRAS hope­ful so­tora­sib in NSCLC

Am­gen is look­ing to go where no oth­er drug­mak­er has gone be­fore with the KRAS in­hibitor so­tora­sib, which post­ed big Phase II lung can­cer re­sponse da­ta in late Jan­u­ary. The FDA has been lis­ten­ing, and now it’s ready to give Am­gen its ear.

The FDA will speed­i­ly re­view so­tora­sib’s ap­pli­ca­tion to treat sec­ond-line pa­tients with lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer in what would be the first suc­cess­ful bid to in­hib­it KRAS, Am­gen said in a re­lease.

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