FDA approves Vyloy with chemotherapy for some gastric cancers, approves diagnostic device
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Key takeaways:
- Zolbetuximab-clzb is intended for adults with claudin 18.2-positive tumors.
- The drug application was granted priority review, fast track and orphan drug designation by the FDA.
The FDA approved Vyloy with chemotherapy to treat locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults, according to a press release.
Vyloy (zolbetuximab-clzb, Astellas Pharma US Inc.) is a claudin 18.2 (CLDN-18.2)-directed cytolytic antibody. The approval is for use of the drug with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment in patients with CLDN-18.2-positive tumors that have been confirmed by an FDA-approved test.
The FDA also authorized Ventana CLDN18 (43-14A) RxDx Assay by Ventana Medical Systems Inc./Roche Diagnostics as a companion diagnostic device to identify patients with gastric or gastroesophageal junction adenocarcinoma who could be treated with zolbetuximab.
The approval is based on two double-blind, multicenter trials of patients with CLDN-18.2- positive advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. In the trials, the major efficacy outcome measure was progression-free survival.
In the SPOTLIGHT trial, investigators studied 565 patients who received either zolbetuximab-clzb with mFOLFOX6 chemotherapy or the chemotherapy with placebo. Researchers found median progression-free survival of 10.6 months in the zolbetuximab-clzb group vs. 8.7 months for the placebo group. Most common serious adverse events included vomiting, nausea and neutropenia.
In the GLOW trial, researchers studied 507 patients who received either zolbetuximab-clzb with capecitabine and oxaliplatin chemotherapy or the chemotherapy with placebo. Investigators found median progression-free survival was 8.2 months for the zolbetuximab-clzb group vs. 6.8 months for the placebo group. Common serious adverse events included vomiting, nausea and decreased appetite.
The drug application was granted priority review, fast track and orphan drug designation by the FDA, according to the release.
Reference:
FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric-or-gastroesophageal-junction-adenocarcinoma. Published Oct. 18, 2024. Accessed Oct. 18, 2024.
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