FDA Approves VYLOY for Advanced, HER2-Negative Gastric and Gastroesophageal Junction Cancers

VYLOY (zolbetuximab-clzb), in combination with chemotherapy, has been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with advanced, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with claudin (CLDN) 18.2 positive-tumors. VYLOY was developed by Astellas Pharma, Inc.

“The approval of VYLOY as the first and only targeted therapy for CLDN18.2-positive patients in the U.S. 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,” said Moitreyee Chatterjee-Kishore, Phd, MBA, senior vice president and head of Immuno-Oncology Development at Astellas Pharma, via a press release. “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.”

The approval comes on the heels of two phase III clinical trials. The GLOW trial assessed VYLOY plus CAPOX, a combination chemotherapy regimen, versus placebo plus CAPOX. The SPOTLIGHT trial assessed VYLOY plus mFOLFOX6, another combination chemotherapy regimen, versus placebo plus mFOLFOX6. Both studies met the primary and secondary endpoints of progression-free survival (PFS) and overall survival (OS), respectively.

To identify patients eligible for VYLOY, Astellas partnered with Roche, which created an FDA-approved immunohistochemistry (IHC) test that measures CLDN18.2 status. In both clinical trials, 38% of screened patients presented with CLDN18.2-positive tumors.

VYLOY is now approved in the U.S., Japan, the European Union, the United Kingdom, and South Korea. It was approved earlier this year in Japan, which marked the first global approval of the treatment.

“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 at Harvard Medical School and medical oncologist at Massachusetts General Hospital, via a press release. “The approval of VYLOY, based on the pivotal phase 3 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.”