Astellas Pharma has received FDA approval for Vyloy in gastric adenocarcinoma, making it the first and only CLDN18.2 targeted therapy to be approved in the US.
The drug — otherwise called Zolbetuximab-clzb — has been recommended for use in first-line treatment alongside chemotherapy, and is suitable for unresectable or metastatic indications.
Patients should also be HER2 negative and CLDN18.2 positive.
The FDA's decision was based on the results of the SPOTLIGHT and GLOW clinical trials.
These indicated that Vyloy plus chemotherapy could extend progression-free survival (PFS) in patients, while also improving overall survival (OS) when compared to chemotherapy alone.
To determine who would be eligible for Vyloy in clinical trials, Astellas and Roche collaborated on the CDx test, allowing them to ensure patients who were CLDN18.2+ were given access to this therapeutic.
Roche has also developed a CLDN18 assay, RxDx, that can identify patients who are CLDN18.2+, which was used in both the GLOW and SPOTLIGHT trials.
This assay is available in various laboratories across the US, and will likely be more widely distributed across the US soon.
Astellas' Senior VP and Head of Immuno-Oncological Development, Moitreyee Chatterjee-Kishore, commented: “The approval of VYLOY as the first and only targeted therapy for CLDN18.2+ patients in the US further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers, which are often only discovered at the advanced stage."
"This achievement is the result of years of dedicated research and development focused on targeting a novel biomarker, and we are grateful to the patients, investigators, and Astellas team members who have made this important advancement for patients a reality.”
Samuel J. Klempner, Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, added:
“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."
"The approval of VYLOY, based on the pivotal Phase III SPOTLIGHT and GLOW trials, brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those on the frontlines of treatment decision-making.”
Vyloy is now approved in five markets worldwide, including Japan, the UK, the EU and South Korea.