Pa­tient death forces FDA to slap a hold on study us­ing com­bo from Ad­vax­is, As­traZeneca -- biotech's shares plunge

The FDA has slapped a clin­i­cal hold on a com­bo ther­a­py us­ing Ad­vax­is’ $ADXS ax­al­imo­gene filolis­bac along with As­traZeneca’s ap­proved PD-L1 Imfinzi fol­low­ing the death of a pa­tient in their Phase I/II tri­al.

Re­searchers were study­ing the com­bi­na­tion of drugs for pa­tients with HPV-trig­gered head-and-neck as well as cer­vi­cal can­cer. In this par­tic­u­lar case, a pa­tient died from res­pi­ra­to­ry fail­ure fol­low­ing the 6th treat­ment cy­cle. And now reg­u­la­tors want to put the study on hold while they ex­am­ine the im­pli­ca­tions for oth­ers in the tri­al.

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