Treats locally advanced unresectable or metastatic human epidermal growth factor receptor…. BLA 761365, held by Astellas. Zolbetuximab-Clzb.
As of Nov 13, 2026, BLA 761365 (Vyloy), held by Astellas, was first approved by FDA on Oct 18, 2024, with 1 approved supplement and 1 published complete response letter.
VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. VYLOY is a claudin 18.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 4, 2024 | IMAB362Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyloy100MG · injectable;injection | Zolbetuximab-Clzb | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
