J&J files U.S. application for bispecific antibody for type of lung cancer

 

• Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals has submitted a marketing application to the FDA seeking approval of amivantamab, a fully-human epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET) bispecific antibody, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemo, a Breakthrough Therapy-tagged indication.
• Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
• https://seekingalpha.com/news/3641279-j-and-j-files-u-s-application-for-bispecific-antibody-for-type-of-lung-cancer