The US Food and Drug Administration (FDA) has given special recognition to a new experimental drug called izalontamab brengitecan (iza-bren). This drug, developed by SystImmune and Bristol Myers Squibb, is being tested for patients with advanced non-small cell lung cancer (NSCLC) who have specific gene changes in their tumors. These patients have already tried and failed other targeted treatments and chemotherapy. The FDA’s decision means the drug shows promising results and could help where current treatments fall short. Iza-bren is a special type of medicine that targets and blocks two proteins (EGFR and HER3) that help cancer cells grow, while also delivering a toxic agent to kill them. The FDA based its decision on early study results from trials in China, the US, Europe, and Japan. These studies suggest iza-bren may work better than existing treatments with manageable side effects. ‘This recognition highlights iza-bren’s potential to improve outcomes for patients with advanced lung cancer who have run out of options,’ said Jonathan Cheng, chief medical officer at SystImmune. Lung cancer is the leading cause of cancer deaths worldwide, and new treatments are urgently needed for patients whose cancer no longer responds to standard therapies.