VYLOY is used in conjunction with chemotherapy for the treatment of advanced gastric and gastroesophageal junction cancer. Credit: Emily frost/Shutterstock.com.

Astellas Pharma has gained approval from the US Food and Drug Administration (FDA) for VYLOY (zolbetuximab-clzb), in conjunction with chemotherapy, for the treatment of advanced gastric and gastroesophageal junction (GEJ) cancer.

This is the first US approval for VYLOY, a therapy targeting claudin (CLDN)-18.2-positive tumours identified through an FDA-approved diagnostic assay, Roche’s VENTANA CLDN18 (43-14A) RxDx assay.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The FDA’s decision is grounded in the outcomes of the Phase III, global, multi-centre, double-blind, randomised SPOTLIGHT and GLOW clinical trials.

These studies demonstrated that patients with CLDN18.2-positive tumours experienced significant improvements in progression-free survival (PFS) and overall survival (OS) when treated with VYLOY in combination with chemotherapy, compared to placebo and chemotherapy.

Astellas senior vice-president and immuno-oncology development head Moitreyee Chatterjee-Kishore stated: “The approval of VYLOY as the first and only targeted therapy for CLDN18.2-positive 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.

See Also:

“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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In the SPOTLIGHT trial, VYLOY was evaluated with mFOLFOX6. In the GLOW study, it was combined with CAPOX.

The trials showed that 38% of screened patients had CLDN18.2-positive tumours, defined by a specific level of immunohistochemical staining determined by Roche’s assay.

With FDA approval, VYLOY is authorised in five markets globally, following earlier approvals in Japan, the UK, the European Union and South Korea.

The therapy received its first global approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in March 2024, and gained subsequent endorsements by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in August, the European Commission in September, and South Korea’s Ministry of Food and Drug Safety.

Astellas continues to seek approvals for VYLOY in other regions.