FDA Grants Orphan Drug Designation to Gavo-Cel for Cholangiocarcinoma

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to T-cell therapy gavocabtagene autoleucel (gavo-cel) for the treatment of cholangiocarcinoma.

TCR2 Therapeutics, the manufacturer of gavo-cel, is developing cancer treatments using T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) which recognize and kill cancer cells by harnessing signaling from the entire TCR independent of human leukocyte antigens. TC-110, another therapy developed by TCR2 Therapeutics, is currently being evaluated for the treatment of adult patients with CD19-positive acute lymphocytic leukemia and aggressive or indolent non-Hodgkin lymphoma in a phase I/II clinical trial.

A phase I/II study of gavo-cel in patients with refractory mesothelin-expressing solid tumors, including malignant mesothelioma, ovarian cancer, and cholangiocarcinoma is ongoing.

Source: TCR2 Therapeutics press release, September 2, 2021.