Two pa­tient deaths lead to FDA par­tial hold for Gos­samer tri­al of lym­phoma drug

Gos­samer Bio said last month it had paused a Phase Ib/II study of its BTK in­hibitor due to “ben­e­fit/risk pro­file.” Now, the biotech re­vealed in an SEC fil­ing that two pa­tient deaths oc­curred in the study and the FDA has slapped a par­tial clin­i­cal hold on the pro­gram.

The fed­er­al agency placed the hold on tri­als of the oral drug can­di­date af­ter se­ri­ous ad­verse events, in­clud­ing “atri­al fib­ril­la­tion, a sud­den death event and a fa­tal in­tracra­nial he­m­or­rhage,” Gos­samer said in the Mon­day fil­ing. Fi­nance and op­er­at­ing chief Bryan Gi­rau­do con­firmed in a phone call that the death event and fa­tal he­m­or­rhage were two dif­fer­ent pa­tients in the tri­al of peo­ple with cen­tral ner­vous sys­tem lym­phoma.

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