By Colin Kellaher

 

Johnson & Johnson's Janssen Pharmaceutical Cos. unit on Thursday said it filed for U.S. Food and Drug Administration approval of amivantamab in a form of non-small cell lung cancer.

Janssen said the filing covers patients with metastatic non-small cell lung cancer with epidermal growth factor receptor, or EGFR, exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The company said its application is the first-ever regulatory submission for the treatment of those patients, for whom there are no FDA-approved targeted treatment options.

Non-small cell lung cancer accounts for 80% to 85% of all lung cancers, the most common cancer worldwide. EGFR mutations, which lead to uncontrolled cancer-cell growth and division, are among the most common mutations in non-small cell lung cancer, Janssen said.

The J&J unit said it has established an expanded access program for U.S. patients who may be eligible to obtain access to amivantamab while the FDA reviews the drug.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

December 03, 2020 09:13 ET (14:13 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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