J&J’s Janssen nabs new indication, full approval for cancer drug Rybrevant

John­son & John­son’s Janssen on Fri­day earned an FDA ap­proval for its can­cer drug Ry­bre­vant (ami­van­tam­ab-vmjw) for the first-line treat­ment of lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer with epi­der­mal growth fac­tor re­cep­tor (EGFR) ex­on 20 in­ser­tion mu­ta­tions in com­bi­na­tion with oth­er chemother­a­pies.

The ap­proval, which came about a month ahead of time, co­in­cid­ed with the FDA’s con­ver­sion of an­oth­er ac­cel­er­at­ed ap­proval for Ry­bre­vant to a full ap­proval to treat NSCLC with EGFR ex­on 20 in­ser­tion mu­ta­tions in pa­tients whose dis­ease has pro­gressed on or af­ter plat­inum-based chemother­a­py. The ap­provals were based on pos­i­tive re­sults from Janssen’s PA­PIL­LON study, which eval­u­at­ed pro­gres­sion-free sur­vival as a pri­ma­ry out­come and over­all sur­vival as a sec­ondary out­come.

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