The agency approved the autologous CAR T-cell therapy based on data showing that around 62 percent of patients had no signs of cancer after a single infusion.

In the Phase I portion of the trial, there were no reported serious adverse events and a 100 percent complete response rate at the highest dose level of EB103.

The regimen reduces the steps required to administer tumor-specific antibodies and a radioactive payload to carcinoembryonic antigen-positive tumors.

The company has also received orphan drug, rare pediatric disease, and fast-track designations for LTS-101 as a potential treatment for the fatal neurodegenerative disease.