J&J’s bispecific wins first approval for exon 20 lung cancer niche

Swift approval for amivantamab, now trademarked Rybrevant, gives J&J first crack at non-small cell lung cancer driven by exon 20 insertions, a hard-to-treat subset. The accelerated approval comes two months before the FDA’s goal, and was based on data presented at World Lung earlier this year that included a 40% response rate. Developers have previously struggled to hit this mutation effectively with small molecules; Rybrevant is notable for being a bispecific against EGFR and Met. Rybrevant’s infused administration could become a hindrance, a theory that might be tested should Takeda’s small molecule mobocertinib win approval by its October 26 Pdufa date. Mobocertinib data at World Lung were arguably less impressive than Rybrevant’s, although the evidence for both is likely to evolve. Spectrum seems to have restricted its work with poziotinib to Her2 exon 20 mutations, which would not make it a direct competitor. Otherwise the pipeline includes a couple of projects in development in China, and BDTX-189 from Black Diamond, which underwhelmed last week with data due to be presented at Asco next month. Cullinan is also presenting an update, on CLN-081, at the conference.