Turning Point Gets FDA Orphan Designation for TPX-0022 in Gastric Cancer
17 June 2021 - 11:18PM
Dow Jones News
By Colin Kellaher
Turning Point Therapeutics Inc. on Thursday said the U.S. Food
and Drug Administration granted orphan-drug designation to its MET
inhibitor TPX-0022 for the treatment of patients with gastric
cancer, including gastroesophageal junction adenocarcinoma.
The San Diego clinical-stage oncology company said there are
currently no approved MET inhibitors for the treatment of gastric
cancer and gastroesophageal junction adenocarcinoma.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect fewer than 200,000
people in the U.S. and provides for an extended marketing
exclusivity period against competition.
Turning Point said TPX-0022 was generally well-tolerated and
showed clinical activity in a Phase 1 study in patients with
MET-amplified gastric cancer.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 17, 2021 09:06 ET (13:06 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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