TCR Therapeutics Gets FDA Orphan Designation for Gavo-cel in Bile-Duct Cancer
September 02 2021 - 10:15AM
Dow Jones News
By Colin Kellaher
TCR Therapeutics Inc. on Thursday said the U.S. Food and Drug
Administration granted orphan-drug designation to gavo-cel for the
treatment of cholangiocarcinoma, a group of cancers that begin in
the bile ducts.
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.
TCR, a Cambridge, Mass., clinical-stage cell-therapy company is
studying gavo-cel in a Phase 1/2 clinical trial to treat patients
with non-small cell lung cancer, ovarian cancer, malignant
pleural/peritoneal mesothelioma and cholangiocarcinoma.
The company said new data from the dose-escalation portion of
the study would be presented later this month.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 02, 2021 10:00 ET (14:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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