Richard Pazdur (FDA)

Three-day FDA ad­comm to fea­ture un­prece­dent­ed re­view of Mer­ck, Roche and BMS ac­cel­er­at­ed ap­provals

The FDA is con­tin­u­ing its re­view of can­cer drugs that have won ac­cel­er­at­ed ap­provals with three days of ad­vi­so­ry com­mit­tee meet­ings in late April to in­ves­ti­gate dif­fer­ent in­di­ca­tions for Roche’s Tecen­triq, Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo — rais­ing the prospect that we’ll see a slew of new in­di­ca­tions pulled off the mar­ket as the agency push­es a broad re­assess­ment of their snap OKs in re­cent years.

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