HQ Team
October 21, 2024: Astellas Pharma Inc.’s therapy to treat a form of gastric cancer got approval from the US drug regulator, according to a company statement.
Vyloy or zolbetuximab-clzb, a combination of fluoropyrimidine- and platinum-containing chemotherapy, was approved by the Food and Drug Administration after end-stage trials met the goals of progression-free survival and overall survival.
It is meant for adults with advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.
The first-line treatment is the only CLDN18.2-targeted therapy approved in the US, according to the statement.
CLDN18.2-positive patients refer to individuals whose tumours express the claudin 18 isoform 2 (CLDN18.2) at specific levels, indicating a potential target for certain cancer therapies, particularly in gastric and gastroesophageal junction (GEJ) cancers.
Immunohistochemistry testing
CLDN18.2 Positivity is defined by the percentage of tumour cells exhibiting moderate to strong membranous staining for CLDN18.2 during immunohistochemistry testing.
“While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients,” said Samuel J. Klempner, MD, Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, Boston.
Vyloy “brings forward a novel biomarker and new therapy for patients whose tumours are CLDN18.2 positive and for those on the frontlines of treatment decision-making,” he said.
Astellas collaborated with Roche on the newly approved immunohistochemistry companion diagnostic test to identify patients who may be eligible for Vyloy.
Vyloy is now approved in five markets worldwide — Japan, the United Kingdom, the European Union, South Korea and the US. Japan’s Ministry of Health, Labour and Welfare approved the therapy on March 26, 2024.
In August, it was approved by the UK Medicines and Healthcare products Regulatory Agency. In the next month, the European Union gave a marketing authorisation.
