FDA label expansions: August saw broadening of labels for Rybrevant, Jemperli

In August FDA approved at least nine supplemental BLAs and NDAs seeking label expansions to include new indications or younger population. 

An sBLA for Rybrevant amivantamab from Johnson & Johnson (NYSE:JNJ) was approved for use with Lazcluze lazertinib as first-line treatment for non-small cell lung cancer patients with EGFR exon 19 deletions or exon 21 858R substitution mutations. FDA approved the sBLA concurrently with the Lazcluze NDA. In Phase III MARIPOSA trial the combination reduced the risk of disease progression or death by 30% (HR=0.70) compared with Tagrisso osimertinib from AstraZeneca plc (LSE:AZN; NYSE:AZN), with a median PFS of 23.7 months vs.16.6 months...