D-day: No­var­tis ar­rives at a cross­road in the block­buster race to win the first FDA OK for CAR-T

Three years of in­tense com­pe­ti­tion and bil­lions of dol­lars in in­vest­ments in­to de­vel­op­ing the world’s first CAR-T ther­a­py has come down to the wire to­day with the first FDA pan­el re­view for No­var­tis’ lead­ing CTL019 (ti­s­agen­le­cleu­cel) ther­a­py.

Ob­servers crowd­ed in­to the pre­sen­ta­tion room this morn­ing, rub­bing shoul­ders with CAR-T celebs like Penn’s Carl June with many, many more look­ing on­line as No­var­tis and reg­u­la­tors be­gan the painstak­ing process of break­ing down the man­u­fac­tur­ing process that goes in­to the lengthy and com­plex task in­volved in mak­ing these drugs. While most of these pan­el re­views come down to as­sess­ing the da­ta and how re­sults stack up against the gold stan­dard on safe­ty and ef­fi­ca­cy, the agency to­day wants their ex­perts to care­ful­ly con­sid­er if these drugs can con­sis­tent­ly be made to or­der in a safe fash­ion by man­u­fac­tur­ers who are still fine tun­ing their de­liv­ery times. In ad­di­tion, they’ll need to dis­cuss the po­ten­tial threat of a tox­i­c­i­ty pro­file that has yet to be ful­ly es­tab­lished or com­plete­ly un­der­stood.

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