> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Janssen Lung Cancer Therapy Approved
- URL: https://www.fdaweb.com/janssen-lung-cancer-therapy-approved/
- Published: 2021-05-21T12:00:00.000Z
- Updated: 2026-09-14T16:59:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149378

FDA has approved a Janssen Pharmaceutical NDA for Rybrevant (amivantamab-vmjw) for treating adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations — epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The agency also approved Guardant Health’s Guardant360 CDx as a companion diagnostic for determining patient eligibility for the therapy.

Approval was based on data from 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. “In the trial population in which all patients received Rybrevant, the overall response rate was 40%,” an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-subset-non-small-cell-lung-cancer?ref=fdaweb.com) says. “The median duration of response was 11.1 months, with 63% of patients having a duration of response of six months or more.”