David Reese (Amgen)

Am­gen show­cas­es its last big round of promis­ing KRAS G12C da­ta for so­tora­sib. Next up: A like­ly mar­ket­ing cam­paign for a break­through ther­a­py

Am­gen is show­ing off the last, break­through round of da­ta it has from the piv­otal study for its KRAS G12C drug so­tora­sib in non-small cell lung can­cer — the da­ta they’ll be go­ing to mar­ket with, if reg­u­la­tors come through with an ac­cel­er­at­ed OK soon, which is wide­ly ex­pect­ed.

The da­ta are ar­riv­ing in ad­vance of the sched­uled re­lease for the World Con­fer­ence on Lung Can­cer, cour­tesy of an em­bar­go break on the PR for the da­ta, which sur­faced ear­ly in Chi­na. But that helps il­lus­trate just how ea­ger­ly await­ed the da­ta are as the FDA re­views the re­sults for a drug that cur­rent­ly has “break­through” sta­tus from late last year, putting the pro­gram on a short­cut to a near-term mar­ket­ing de­ci­sion.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA