Ju­ly 12 FDA pan­el re­view looms as a wa­ter­shed mo­ment in No­var­tis’ cam­paign to win an his­toric new drug OK

If you have any in­ter­est in the CAR-T field, mark down Wednes­day, Ju­ly 12 as a red let­ter day.

The FDA post­ed a note on Tues­day say­ing that its group of out­side can­cer ex­perts will gath­er that day to dis­cuss the phar­ma gi­ant’s ap­pli­ca­tion and vote on whether No­var­tis $NVS should get a mar­ket­ing ap­proval for its lead­ing CAR-T CTL019 (ti­s­agen­le­cleu­cel-T) as a new treat­ment for re­lapsed and re­frac­to­ry pe­di­atric B-cell acute lym­phoblas­tic leukemia. And on Mon­day pre­ced­ing the pan­el re­view the FDA will be ex­pect­ed to de­liv­er its in­ter­nal re­view of the ther­a­py, which will fur­ther tip its hand on what reg­u­la­tors are think­ing about the da­ta for a drug award­ed its break­through ther­a­py des­ig­na­tion.

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