Astellas’ first-in-class, claudin-targeted therapy receives FDA approval for certain types of stomach cancer

The FDA on Friday logged out To Astellas PharmaThe cytolytic antibody zolbetuximab-clzb, now marketed as Vyloy, is intended for the treatment of adult patients with locally advanced, unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction.

According to Astellas, Vyloy is the first and only claudin 18.2-targeted therapy approved for these indications in the United States. The labeling of Vyloy covers first-line use in claudin 18.2-positive patients with HER2-negative tumors and in combination with fluoropyrimidine- and platinum-containing chemotherapy.

Samuel Klempner, a medical oncologist at Massachusetts General Hospital in Boston, said in a statement that Vyloy’s approval “creates a novel biomarker and therapy for patients with CLDN18.2-positive tumors,” for whom “there remains a tremendous unmet need.” There is a need.” ” despite significant “advances in the first-line treatment of locally advanced unresectable and metastatic gastric and gastroesophageal junction (GEJ) cancers.”

Plumber previously worked as a consultant or consultant for Astellas.

Friday’s approval is supported by data from the Phase III SPOTLIGHT and GLOW trials, which together show that Vyloy-based regimens could significantly improve patient survival. In both studies, Vyloy was well tolerated, with the most common side effects being nausea, vomiting and decreased appetite.

In SPOTLIGHT, Vyloy was combined with mFOLFOX6 – a treatment regimen that includes oxaliplatin, leucovorin and fluorouracil – and tested against placebo plus mFOLFOX6. Astellas published data from the study in January 2023. advertises a reduction of almost 25% the risk of disease progression or death. The median progression-free survival at this time was 10.61 months in the Vyloy arm, compared to 8.67 months in the placebo group.

Overall survival was also significantly longer in patients treated with the Vyloy combination.

Astellas followed the SPOTLIGHT ad with a data drop from GLOW in March 2023, which combined Vyloy with the chemo combination of capecitabine and oxaliplatin, better known as CAPOX. Compared to placebo plus CAPOX, Vyloy therapy reduced the risk of disease progression or death more than 31% and the risk of death by almost 23%.

Vyloy’s approval on Friday comes after a first rejection in January 2024. At that time, the FDA found unresolved deficiencies at a third-party manufacturing facility — although the regulator found no problems with Astellas’ data or Vyloy’s safety. Astellas then resubmitted its application, which was rejected by the FDA accepted in May 2024 and stated November 9th as the target date.