FDA officials raise concerns with immunotherapy overuse for early-stage cancer patients: #AACR24

SAN DIEGO — As im­munother­a­pies be­come more wide­ly used be­fore and af­ter can­cer surgery, the FDA is wor­ried that some pa­tients may be re­ceiv­ing the ther­a­pies even when they don’t need them.

Im­mune check­point in­hibitors, such as Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo, have be­come sta­ples in can­cer care in the past decade, and in 2023, Keytru­da was the world’s top-sell­ing drug. Their use has ex­pand­ed as phar­ma com­pa­nies have won ap­provals of the drugs in ear­li­er-stage can­cers by pair­ing them with surgery.

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