J&J Unit Seeks FDA OK of Amivantamab in Form of Non-Small Cell Lung Cancer
03 Décembre 2020 - 03:28PM
Dow Jones News
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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