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FDA Medication Tracker

← All approvals · Cancer · 2024

Vyloy (zolbetuximab-clzb)

The FDA approved Vyloy (zolbetuximab-clzb) on October 18, 2024 to treat gastric or gastroesophageal junction adenocarcinoma.
Brand name
Vyloy
Generic name
zolbetuximab-clzb
FDA approval date
October 18, 2024
Approved use (FDA wording)
To treat gastric or gastroesophageal junction adenocarcinoma
Company
Astellas
Application
BLA761365
Dosage form / route
INJECTABLE · INJECTION
Drug class (EPC)
Claudin 18.2-directed Cytolytic Antibody [EPC]
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

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 [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal …

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.