FDA grants orphan drug designation to gavo-cel for cholangiocarcinoma
The FDA granted orphan drug designation to gavo-cel for treatment of cholangiocarcinoma.
Gavo-cel (TCR2 Therapeutics) is a novel T-cell therapy.
TCR2 Therapeutics’ proprietary T-cell receptor fusion construct T cells (TRuC2-T cells) are designed to recognize and kill cancer cells by harnessing signaling from the entire T-cell receptor independent of HLA, according to a company-issued press release.
Preclinical studies showed TRuC-T cells may have greater anti-tumor activity than chimeric antigen receptor T cells while secreting lower levels of cytokine release.
A phase 1/phase 2 trial is underway to evaluate gavo-cel for patients with mesothelin-positive non-small cell lung cancer, ovarian cancer, malignant pleural/peritoneal mesothelioma or cholangiocarcinoma.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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