FDA Approves Astellas’ VYLOY for HER2-Negative Gastric and GEJ Adenocarcinoma

Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) for use in combination with fluoropyrimidine- and platinum-containing chemotherapy. This approval is for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with claudin (CLDN) 18.2 positive tumors, as determined by an FDA-approved test. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.

Publish Date: 21-10-2024 Source: Astellas Pharma Inc.

Advanced or metastatic gastroesophageal junction adenocarcinoma, often referred to as GEJ adenocarcinoma, represents a particularly challenging and aggressive cancer subtype. This malignancy originates in the cells lining the junction between the stomach and the esophagus, known as the gastroesophageal junction (GEJ). The tumor’s epicenter is situated within the GEJ region in this type of carcinoma. GEJ adenocarcinoma is associated with a substantial clinical burden due to its high propensity for advancing to later stages and its generally poor prognosis. The disease’s progression to an advanced or metastatic state intensifies the challenges patients and healthcare providers face. Metastatic GEJ adenocarcinoma implies that the cancer has spread from its initial site to other body parts, significantly reducing the chances of successful treatment and long-term survival. Most patients diagnosed with GEJ adenocarcinoma present with advanced stages of the disease. Subtle or nonspecific symptoms in the early stages frequently lead to delayed diagnosis. Consequently, the potential for successful curative treatment diminishes, and many patients are left with limited treatment options. Factors contributing to the advanced presentation include the tumor’s aggressive nature and tendency to remain asymptomatic until later stages. The Siewert classification is an essential framework medical professionals use to categorize adenocarcinomas located within 5 cm of the GEJ. This classification system divides GEJ adenocarcinomas into three distinct types, each with unique characteristics and anatomical locations:

Type I Adenocarcinoma: This type is situated 1–5 cm above the GEJ and is found in the distal esophagus.
Type II Adenocarcinoma: Characterized as true cardia carcinoma, this type is located between 1 cm above and 2 cm below the GEJ.
Type III Subcardial Carcinoma: This type is positioned 2–5 cm below the GEJ, specifically in the subcardial region.

Diagnosing advanced or metastatic gastroesophageal junction adenocarcinoma involves a combination of clinical evaluation, imaging techniques, and often histopathological confirmation. The treatment approach for advanced or metastatic gastroesophageal junction adenocarcinoma is often multidisciplinary and depends on factors like the tumor’s stage, location, patient’s overall health, and individual preferences.

The incidence of Gastroesophageal junction adenocarcinoma ranges from 2.8 to 3.9 per 100,000 population in the USA.

However, the current Advanced or Metastatic Gastroesophageal Junction Adenocarcinoma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (CS1001, AK129, ASKB589, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Advanced or Metastatic Gastroesophageal Junction Adenocarcinoma treatment. The key companies in the advanced development stage are CStone Pharmaceuticals, Akeso, AskGene Pharma, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Advanced or Metastatic Gastroesophageal Junction Adenocarcinoma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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