J&J guns for quick drug OK in lung can­cer niche, tak­ing the first step chal­leng­ing As­traZeneca in EGFR

J&J has leapt straight from a Phase I tri­al to a BLA for ami­van­tam­ab, a bis­pe­cif­ic an­ti­body de­signed to treat a sub­set of metasta­t­ic non-small cell lung can­cer pa­tients by tar­get­ing EGFR and MET si­mul­ta­ne­ous­ly.

While the first epi­der­mal growth fac­tor re­cep­tor in­hibitors were ap­proved more than a decade ago, this is the first drug tar­get­ing EGFR ex­on 20 in­ser­tion mu­ta­tions to ever be filed with the FDA, the com­pa­ny said.

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