J&J antibody nabs accelerated review for lung cancer

The FDA designates Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies’ JNJ-6372 a Breakthrough Therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose cancer has progressed on or after platinum-based chemotherapy.

Phase 1-stage JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.

NSCLC with EGFR Exon 20 insertion mutations is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy and represents a poor prognosis for patients. The current standard-of-care is conventional cytotoxic chemo.

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/3550299-j-and-j-met-antibody-nabs-accelerated-review-status-for-certain-lung-cancer-patients