Drugs to Watch: Regulatory Focus – Zolbetuximab

Investigational drug takes advantage of an accelerated review process for oncology treatments

Zolbetuximab is an investigational first-in-class monoclonal antibody treatment for patients with CLDN18.2-positive, HER2-negative, metastatic gastric (mG) or gastroesophageal junction (GEJ) adenocarcinoma—a cancer that is notoriously difficult to treat and in need of new therapeutic options.

The drug is in review under the FDA’s Real-Time Oncology Review (RTOR) program. If approved by the FDA, zolbetuximab would be the first therapy for these patients in the United States.

This report explores:

Disease and competitive landscape
Regulatory strategy (e.g., which pathways to pursue in key markets)
Key areas of regulatory focus, such as safety concerns, pharmacovigilance, use in specific populations and effectiveness
Outstanding safety and efficacy concerns