Announcement and Regulatory Approval

Astellas Pharma India Private Limited issued a press release on 30 July 2026 stating that the Central Drugs Standard Control Organization (CDSCO) has approved VYLOY™ (zolbetuximab) in combination with fluoropyrimidine‑ and platinum‑containing chemotherapy for first‑line treatment of adult patients in India with locally advanced unresectable or metastatic gastric or gastro‑esophageal junction (GEJ) adenocarcinoma that are HER2‑negative and CLDN18.2‑positive. The approval makes VYLOY the first and only CLDN18.2‑targeted therapy available in India for this patient population.

Indication and Diagnostic Requirement

The indication specifies use in adults whose tumors test positive for CLDN18.2. Eligibility is determined using the FDA‑approved VENTANA CLDN18 (43‑14A) RxDx Assay from Roche, an immunohistochemistry (IHC) test that identifies CLDN18.2 expression.

Clinical Evidence Supporting Approval

SPOTLIGHT Trial

  • Design: Global, multicenter, double‑blind, randomized Phase 3 study comparing VYLOY + mFOLFOX6 versus placebo + mFOLFOX6.
  • Enrollment: 565 patients across 215 sites in North America, Europe, South America, Asia, and Australia.
  • Median progression‑free survival (PFS): 10.6 months (95 % CI 8.9‑12.5) with VYLOY vs 8.7 months (95 % CI 8.2‑10.3) with placebo; hazard ratio (HR) 0.751, one‑sided p‑value 0.0066.
  • Median overall survival (OS): 18.2 months (95 % CI 16.4‑22.9) vs 15.5 months (95 % CI 13.5‑16.5); HR 0.750, p‑value 0.0053.
  • Serious adverse reactions occurred in 45 % of VYLOY‑treated patients; most common ≥2 % were vomiting (8 %), nausea (7 %), neutropenia (2.9 %), febrile neutropenia (2.9 %), diarrhea (2.9 %), intestinal obstruction (3.2 %), pyrexia (2.5 %), pneumonia (2.5 %), respiratory failure (2.2 %), pulmonary embolism (2.2 %), decreased appetite (2.1 %), and sepsis (2.0 %).
  • Fatal adverse reactions were reported in 5 % of patients, including sepsis (1.4 %), pneumonia (1.1 %), respiratory failure (1.1 %), intestinal obstruction (0.7 %), acute hepatic failure (0.4 %), acute myocardial infarction (0.4 %), disseminated intravascular coagulation (0.4 %), encephalopathy (0.4 %), and upper gastrointestinal hemorrhage (0.4 %).
  • Permanent discontinuation due to adverse events occurred in 20 % of patients, most commonly because of nausea and vomiting. Dose interruptions were required in 75 % of patients, driven mainly by nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension.

GLOW Trial

  • Design: Global, multicenter, double‑blind, randomized Phase 3 study comparing VYLOY + CAPOX versus placebo + CAPOX.
  • Enrollment: 507 patients across 166 sites in the same regions as SPOTLIGHT.
  • Median PFS: 8.2 months (95 % CI 7.5‑8.8) with VYLOY vs 6.8 months (95 % CI 6.1‑8.1) with placebo; HR 0.687, p‑value 0.0007.
  • Median OS: 14.4 months (95 % CI 12.3‑16.5) vs 12.2 months (95 % CI 10.3‑13.7); HR 0.771, p‑value 0.0118.
  • Serious adverse reactions occurred in 47 % of VYLOY‑treated patients; most common ≥2 % were vomiting (6 %), nausea (4.3 %), decreased appetite (3.9 %), thrombocytopenia (3.1 %), upper gastrointestinal hemorrhage (2.8 %), diarrhea (2.8 %), pneumonia (2.4 %), pulmonary embolism (2.3 %), and pyrexia (2.0 %).
  • Fatal adverse reactions were reported in 8 % of patients, including sepsis (1.2 %), pneumonia (0.4 %), death (0.8 %), upper gastrointestinal hemorrhage (0.8 %), cerebral hemorrhage (0.8 %), abdominal infection (0.4 %), acute respiratory distress syndrome (0.4 %), cardio‑respiratory arrest (0.4 %), thrombocytopenia (0.4 %), disseminated intravascular coagulation (0.4 %), dyspnea (0.4 %), gastric perforation (0.4 %), hemorrhagic ascites (0.4 %), procedural complication (0.4 %), sudden death (0.4 %), and syncope (0.4 %).
  • Permanent discontinuation due to adverse events occurred in 19 % of patients, most commonly because of vomiting. Dose interruptions were required in 55 % of patients, with nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion‑related reactions, and abdominal pain being the leading causes.

Dosage Regimen

The recommended zolbetuximab dosing when combined with fluoropyrimidine‑ and platinum‑based chemotherapy is an initial 800 mg/m² intravenous infusion, followed by either 600 mg/m² every three weeks or 400 mg/m² every two weeks.

Disease Burden in India

According to WHO‑IARC data, approximately 68,548 individuals in India are living with gastric or GEJ cancer, with an annual mortality of 45,392. The five‑year relative survival rate for metastatic disease is 8.1 %.

Product Profile and Mechanism

VYLOY™ (zolbetuximab) is a first‑in‑class monoclonal antibody that binds the transmembrane protein claudin‑18.2. It induces tumor cell death through antibody‑dependent cellular cytotoxicity (ADCC) and complement‑dependent cytotoxicity (CDC).

Company Background and Disclaimer

Astellas is a global life‑sciences company with a focus on oncology, ophthalmology, urology, immunology, and women’s health. The press release includes standard forward‑looking statements and cautions that actual results may differ due to economic conditions, regulatory changes, currency fluctuations, launch delays, competitive pressures, and intellectual‑property risks.

Regulatory and Safety Information

VYLOY is a prescription‑only medicine approved by CDSCO and must be prescribed by qualified medical professionals. Safety inquiries can be submitted via Astellas’ webform. The release clarifies that it is not an advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, or the Drugs and Cosmetics Act, 1940.