Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are Claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
Zolbetuximab-clzb is a Claudin 18.2-directed cytolytic antibody, and its approval is supported by the results from the Phase III SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study compared Vyloy plus mFOLFOX6 (a combination chemotherapy regimen including oxaliplatin, leucovorin, and fluorouracil) to placebo plus mFOLFOX6, enrolling 565 patients. The study showed an average progression-free survival (PFS) of 10.6 months for the zolbetuximab/chemo group versus 8.7 months for the placebo/chemo group. The average overall survival (OS) was 18.2 months for the zolbetuximab/chemo group and 15.5 months for the placebo/chemo group.
The GLOW study evaluated Vyloy plus CAPOX (a combination chemotherapy regimen including capecitabine and oxaliplatin) against placebo plus CAPOX in 507 patients. The average PFS for the zolbetuximab/chemo group was 8.2 months, compared to 6.8 months for the placebo/chemo group. The average OS for the zolbetuximab/chemo group was 14.4 months, while it was 12.2 months for the placebo/chemo group.
These clinical outcomes position Vyloy as a significant advancement in the treatment of gastric cancer, particularly for patients with CLDN18.2-positive tumors.- Flcube.com
