Release Date: 05-Oct-2021
US FDA has granted the orphan-drug designation to gavo-cel for the treatment of cholangiocarcinoma, a group of cancers that begin in the bile ducts. TCR Therapeutics is studying gavo-cel in a Phase 1/2 clinical trial to treat patients with non-small cell malignant pleural/peritoneal mesothelioma, cholangiocarcinoma, lung cancer, ovarian cancer. The company also said that new data from the dose-escalation portion of the study would be presented later in September 2021.
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 it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.