The FDA approved the PD-L1 IHC 22C3 pharmDx test as a companion diagnostic to help identify patients who may benefit from pembrolizumab.
In liver cancer, a new antibody called RCT1213 received Orphan Drug Designation for patients with hepatocellular carcinoma who no longer respond to checkpoint inhibitors, highlighting efforts to target the tumor microenvironment.
Progress also continued in the drug pipeline. For cholangiocarcinoma, lirafugratinib (RLY-4008) was granted Priority Review after showing a 46.5% response rate in early trials, with an FDA decision expected by late September 2026. In gastric cancer, givastomig, a therapy targeting CLDN 18.2, is moving forward under an accelerated approval pathway after strong early results showing a 75% response rate, with a phase 3 trial planned later in 2026.
In pancreatic cancer, the FDA supported the design of a phase 3 trial for zabilugene almadenorepvec (VCN-01), an oncolytic virus that will be tested alongside standard chemotherapy to assess survival benefits.
Globally, progress was also reported in gastrointestinal stromal tumors. In Japan, a marketing application was submitted for ripretinib based on results from the INVICTUS trial, which showed a clear improvement in progression-free survival compared with placebo.