CHMP recommends Vyloy (zolbetuximab) to treat gastric or gastro-oesophageal junction (GEJ) adenocarcinoma.- Astellas
On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vyloy, intended for the treatment of gastric or gastro-oesophageal junction (GEJ) adenocarcinoma. The applicant for this medicinal product is Astellas Pharma Europe B.V.
Vyloy will be available as 100 mg powder for concentrate for solution for infusion. The active substance of Vyloy is zolbetuximab, an antineoplastic agent (ATC code: L01FX31). Zolbetuximab is a chimeric (mouse/human) IgG1 antibody directed against the tight junction molecule CLDN18.2, a tissue specific cell surface molecule that is expressed in normal gastric tissue as well as in many human cancers.
The benefit of Vyloy is an improved progression-free survival (PFS) in patients with locally advanced, unresectable or metastatic, HER2-negative, gastric or GEJ adenocarcinoma whose cancer was CLDN18.2-positive, as shown in two studies that evaluated zolbetuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment.
The most common side effects with Vyloy are nausea, vomiting, decreased appetite, neutropenia, neutrophil count decreased, weight loss, pyrexia, hypoalbuminaemia, oedema peripheral, hypertension, dyspepsia, chills, salivary hypersecretion, infusion related reaction and drug hypersensitivity.
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