Roche, Bris­tol My­ers, and Mer­ck prep de­fense for 6 ‘dan­gling’ PD-(L)1 ac­cel­er­at­ed ap­provals, even though they failed con­fir­ma­to­ry tri­als

Should 6 sig­nif­i­cant ac­cel­er­at­ed ap­provals for 3 of the top PD-(L)1s on the mar­ket get yanked or stand un­changed, even though they failed key re­quired stud­ies?

That’s the key ques­tion the FDA will ask out­side ex­perts dur­ing a three-day ad­vi­so­ry com­mit­tee next week, which will eval­u­ate six ac­cel­er­at­ed ap­provals from Roche’s Tecen­triq, Bris­tol My­ers Squibb’s Op­di­vo, and Mer­ck’s Keytru­da, which have all failed to pan out in con­fir­ma­to­ry tri­als.

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