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# Janssen Pharma BLA for Lung Cancer
- URL: https://www.fdaweb.com/janssen-pharma-bla-for-lung-cancer/
- Published: 2020-12-03T12:00:00.000Z
- Updated: 2026-09-14T16:38:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148226

Janssen Pharmaceutical has submitted a BLA for amivantamab for treating patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody has immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications, the company says. The BLA is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib. The study assessed efficacy using overall response rate, clinical benefit rate, duration of response and progression-free survival, it says, adding that amivantamab demonstrated “robust and durable antitumor activity in patients with exon 20 insertion disease, with a manageable safety profile.”