TCR Therapeutics Gets FDA Orphan Designation for Gavo-cel in Bile-Duct Cancer

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)

TCR2 Therapeutics (NASDAQ:TCRR)
Historical Stock Chart
From Apr 2024 to May 2024