FDA grants Leads Biolabs second cancer fast-track

The FDA granted Fast Track Designation to Leads Biolabs' opamtistomig for first-line advanced or metastatic biliary tract cancer just nine days after submission. This is the second Fast Track for the antibody, after one for extrapulmonary neuroendocrine carcinoma. The FDA also recommended the company initiate discussions on U.S. registration plans for opamtistomig in combination with chemotherapy. Opamtistomig is a PD-L1/4-1BB bispecific antibody designed to conditionally activate 4-1BB-mediated T-cell stimulation in the tumor microenvironment. A Phase I/IIa basket study started in 2022 enrolled 175 patients and reported preliminary findings in BTC and other difficult-to-treat tumors. In April 2026 the Phase II combination study advanced into expansion and completed enrollment. China's NMPA granted priority review in July 2026 and accepted an NDA in August 2026 for EP-NEC. About 419,100 new BTC cases were diagnosed worldwide in 2024. Dr. Charles Cai, chief medical officer, called the nine-day decision an encouraging milestone and said the company will continue to advance clinical programs working closely with regulators. Contested: none identified. Opamtistomig is being evaluated across 14 clinical studies.