VYLOY zolbetuximab

Drug Class

Claudin 18.2 monoclonal antibody

Mechanism

Binds to Claudin 18.2 on tumor cells, initiating antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to destroy target cells.

Approved Indication

CLDN18.2-positive, HER2-negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, per its FDA approval.

What This Means For Patients

VYLOY is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2024) — Sources

Pivotal Clinical Evidence

• SPOTLIGHT — Shitara et al., Lancet 2023 (NCT03504397) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-claudin-182-positive-gastric-or-gastroesophageal-junction-cancer
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761356