FDA slams Spec­trum and On­copep­tides can­cer drugs over ef­fi­ca­cy con­cerns ahead of ODAC meet­ing

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee meet­ing on Thurs­day will like­ly be a slaugh­ter for two bio­phar­ma com­pa­nies, Spec­trum Phar­ma­ceu­ti­cals and On­copep­tides, as re­view­ers to­day raised sig­nif­i­cant con­cerns and ques­tions for both spon­sors in brief­ing doc­u­ments re­leased ahead of the meet­ing.

Spec­trum is seek­ing to win an ap­proval for pozi­o­tinib tablets as a treat­ment for pa­tients with pre­vi­ous­ly treat­ed, lo­cal­ly ad­vanced or metasta­t­ic NSCLC har­bor­ing HER2 ex­on 20 in­ser­tion mu­ta­tions. Pozi­o­tinib’s NDA is sup­port­ed by da­ta from a Phase II ZENITH20 tri­al, which showed that the tablets elicit­ed an ORR of 28% (95% CI, 18.9%-38.2%) in this pa­tient pop­u­la­tion, while the me­di­an du­ra­tion of re­sponse (DOR) was 5.1 months (95% CI, 4.2-5.5).

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