Au­to­lus eyes No­vem­ber for po­ten­tial US ap­proval of Tecar­tus ri­val

Au­to­lus Ther­a­peu­tics is ex­pect­ing an FDA de­ci­sion on Nov. 16 for obe­cab­ta­gene au­toleu­cel (obe-cel), its CAR-T hope­ful that would ri­val Gilead’s Tecar­tus in adult acute lym­phoblas­tic leukemia.

Ex­ec­u­tives re­leased the time­line on Mon­day, not­ing that they don’t an­tic­i­pate an FDA ad­vi­so­ry com­mit­tee meet­ing.

Au­to­lus has tout­ed its CD19-di­rect­ed CAR-T as a po­ten­tial­ly safer op­tion than com­peti­tors, point­ing to stud­ies that have shown low lev­els of high-grade cy­tokine re­lease syn­drome (CRS) and im­mune ef­fec­tor cell-as­so­ci­at­ed neu­ro­tox­i­c­i­ty syn­drome (ICANS), two side ef­fects that are com­mon­ly as­so­ci­at­ed with CAR-T treat­ment. When asked about pric­ing, a spokesper­son told End­points News on Mon­day that it is “too ear­ly for us to spec­u­late.”

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