Un­co­or­di­nat­ed and re­dun­dant: FDA's Paz­dur slams check­point in­hibitor de­vel­op­ers for cre­at­ing a 'Wild West'

There’s no deny­ing that Mer­ck’s Keytru­da set a high bar for check­point in­hibitors in de­vel­op­ment every­where. But when it comes to the of­ten re­dun­dant de­vel­op­ment of PD(L)-1 an­ti­bod­ies world­wide, FDA’s top can­cer doc­tors Rick Paz­dur and Ju­lia Beaver are call­ing for more in­dus­try co­or­di­na­tion.

“Ef­forts to cor­ral this en­thu­si­asm should fo­cus on in­creased in­ter­na­tion­al part­ner­ships be­tween spon­sors of ap­proved check­point in­hibitors and those de­vel­op­ing nov­el agents to be used with an­ti–PD-1 and an­ti–PD-L1 an­ti­bod­ies rather than de­vel­op­ing ‘me too’ drugs,” Beaver and Paz­dur wrote Wednes­day in the New Eng­land Jour­nal of Med­i­cine.

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