Novartis's Biologics License Application for Tislelizumab Accepted by FDA
13 Setembro 2021 - 02:44AM
Dow Jones News
By Mauro Orru
Novartis AG said Monday that the Food and Drug Administration
accepted its biologics license application for tislelizumab for
people with esophageal cancer.
The Swiss pharmaceutical company said the FDA's acceptance comes
after a Phase 3 trial where tislelizumab met the primary endpoint
of improvement in overall survival in people with advanced or
metastatic esophageal squamous cell carcinoma who had received
prior systemic therapy.
"We are advancing tislelizumab as a key cornerstone of our
immunotherapy program and PD-1 backbone for combination therapy. We
will work with regulatory authorities to ensure it is available for
people with esophageal cancer as soon as possible," said Jeff
Legos, executive vice president and global head of oncology and
hematology development.
Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94
(END) Dow Jones Newswires
September 13, 2021 01:29 ET (05:29 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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