Initial US Approval:
2024
Key Clinical Studies:
SPOTLIGHT (NCT03504397); GLOW (NCT03653507)
Drug Class/Description:
Claudin 18.2-directed cytolytic antibody
Indications and Usage:
In combination with fluoropyrimidine- and platinum-containing chemotherapy 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 adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
Dosage Administration:
- Administer by intravenous infusion only. Do not administer VYLOY as an intravenous push or bolus.
- The recommended first dose of VYLOY is 800 mg/m2 followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks."
Dosage Forms and Strengths:
For injection: 100 mg lyophilized powder in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
Hypersensitivity reactions including serious anaphylaxis reactions and serious and fatal infusion-related reactions have occurred. Monitor patients during and for at least 2 hours after infusion with VYLOY. Interrupt, slow the rate of infusion or permanently discontinue VYLOY based on severity and type of reaction. Premedicate with antihistamines for subsequent infusions after a hypersensitivity reaction.
Severe nausea and vomiting: Premedicate patients with antiemetics prior to each infusion. Interrupt or permanently discontinue VYLOY based on the severity of the nausea and/or vomiting. Manage patients during and after infusion with antiemetics or fluid replacement.
Adverse Reactions:
The most common adverse reactions (≥15%) for VYLOY in combination with mFOLFOX6 or CAPOX were nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.
The most common laboratory abnormalities (≥15%) for VYLOY in combination with mFOLFOX6 or CAPOX were decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
https://www.astellas.com/us/system/files/vyloy_pi.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
