-
VYLOY is the first and only CLDN18.2-targeted treatment approved in the India
for adult patients with HER2 negative gastric and gastroesophageal junction
(GEJ) adenocarcinoma whose tumors are CLDN18.2 positive -
-
Central Drugs Standard Control Organization approval was based on the
global Phase 3 trials GLOW & SPOTLIGHT where the combination treatment
extended median overall survival and progression free survival outcomes1 -
Mumbai,
India, 30th Jul 2026 : Astellas Pharma India today
announced that VYLOY (zolbetuximab) in combination with chemotherapy is now
available for the first-line treatment of adult patients with gastric or
gastroesophageal junction adenocarcinoma whose tumors are HER2 negative and CLDN18.2 positive in
India. This is the first and
only approved therapy in India to offer extended survival benefit in
combination with chemotherapy, the current standard of care for first-line
treatment of adult gastric or gastroesophageal junction adenocarcinoma whose
tumors are HER2 negative and CLDN18.2 positive.
The approval by Central
Drugs Standard Control Organization was supported by results from the
Phase 3 GLOW & SPOTLIGHT clinical trials. The SPOTLIGHT study evaluated
VYLOY plus mFOLFOX6 (a combination chemotherapy regimen that includes
oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6.
The GLOW study evaluated VYLOY plus CAPOX (a combination chemotherapy regimen
that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.
Both trials met their primary endpoint, progression-free survival (PFS), as
well as a key secondary endpoint, overall survival (OS), in patients treated
with VYLOY plus chemotherapy compared to placebo plus chemotherapy. Across the
SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse
events (TEAEs) reported in the VYLOY treatment arms were nausea, vomiting and
decreased appetite.1
An FDA-approved test is used to identify
patients who may be eligible for VYLOY. The VENTANA CLDN18 (43-14A) RxDx Assay
from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status.6
ABOUT GLOW & SPOTLIGHT TRIALS
SPOTLIGHT is a Phase 3, global,
multi-center, double-blind, randomized study, assessing the efficacy and safety of
zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes
oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as
a first-line treatment in patients with locally advanced unresectable or
metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were
CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in
the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia.
The primary endpoint is progression-free survival (PFS) in participants treated
with the combination of zolbetuximab plus mFOLFOX6 compared to those treated
with placebo plus mFOLFOX6. Secondary endpoints include overall survival (OS),
objective response rate (ORR), duration of response (DOR), safety and
tolerability, and quality-of-life parameters.2
In SPOTLIGHT, median PFS was 10.6 months
(95% CI: 8.9, 12.5) in the zolbetuximab clzb/chemotherapy arm and 8.7 months
(95% CI: 8.2, 10.3) in the placebo/chemotherapy arm (hazard ratio [HR] 0.751
[95% CI: 0.598, 0.942]; 1-sided p-value=0.0066). Median OS was 18.2 months (95%
CI: 16.4, 22.9) and 15.5 months (95% CI: 13.5, 16.5), respectively, (HR 0.750
[95% CI: 0.601, 0.936]; 1-sided p-value=0.0053).2
Serious adverse reactions occurred in 45%
of patients treated with VYLOY in combination with mFOLFOX6; the most common
serious adverse reactions (≥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 occurred in 5% of patients who received VYLOY in combination with
mFOLFOX6 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%), death (0.4%), disseminated intravascular coagulation (0.4%),
encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%). Permanent
discontinuation of VYLOY due to an adverse reaction occurred in 20% of
patients; the most common adverse reactions leading to discontinuation (≥2%)
were nausea and vomiting. Dosage interruptions of VYLOY due to an adverse
reaction occurred in 75% of patients; the most common adverse reactions leading
to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain,
fatigue, and hypertension.2
GLOW is a Phase 3, global, multi-center,
double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus
CAPOX (a combination chemotherapy regimen that includes capecitabine and
oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients
with locally advanced unresectable or metastatic HER2-negative gastric or GEJ
adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 507
patients at 166 study locations in the U.S., Canada, United Kingdom, Europe,
South America, and Asia. The primary endpoint is PFS in participants treated
with the combination of zolbetuximab plus CAPOX compared to those treated with
placebo plus CAPOX. Secondary endpoints include OS, ORR, DOR, safety and
tolerability, and quality-of-life parameters.3
In GLOW, median PFS was 8.2 months (95%
CI: 7.5, 8.8) in the zolbetuximab/chemotherapy arm and 6.8 months (95% CI: 6.1,
8.1) in the placebo/chemotherapy arm (hazard ratio [HR] 0.687 [95% CI: 0.544,
0.866]; 1-sided p-value=0.0007). Median OS was 14.4 months (95% CI: 12.3, 16.5)
and 12.2 months (95% CI: 10.3, 13.7), respectively (HR 0.771 [95% CI: 0.615,
0.965]; 1-sided p-value=0.0118).3
Serious
adverse reactions occurred in 47% of patients treated with VYLOY in combination
with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%),
nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%),
upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%),
pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred
in 8% of patients who received VYLOY in combination with CAPOX 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%),
decreased platelet count (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 of VYLOY due to an adverse reaction occurred in 19%
of patients; the most common adverse reaction leading to discontinuation (≥2%)
was vomiting. Dosage interruption of VYLOY due to an adverse reaction occurred
in 55% of patients; the most common adverse reactions leading to dose
interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia,
anemia, fatigue, infusion-related reaction, and abdominal pain.3
The
recommended zolbetuximab dosage with fluoropyrimidine- and platinum-containing
chemotherapy is:
First
dose: 800 mg/m2 intravenously,
Subsequent
dosages:
600
mg/m2 intravenously every 3 weeks, or
400
mg/m2 intravenously every 2 weeks.2,3
About
VYLOY (zolbetuximab)
VYLOY™
(zolbetuximab) is a claudin 18.2-directed cytolytic antibody that is approved
by the U.S. Food and Drug Administration (FDA) 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. As a first-in-class monoclonal antibody
(mAb), VYLOY targets and binds to CLDN18.2, a transmembrane protein. VYLOY
depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity
(ADCC) and complement-dependent cytotoxicity (CDC).1
Indication
VYLOY,
in combination with fluoropyrimidine- and platinum-containing chemotherapy, is
indicated 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.6
About
Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction
Cancer
Gastric
and gastroesophageal junction (G/GEJ) cancer is the fifth most commonly
diagnosed cancer worldwide. GEJ adenocarcinoma is a cancer that starts at the
area where the esophagus joins the stomach. In India, it is estimated that
68,548 people are living with G/GEJ cancer with a mortality of 45,392 annually.4
Signs and symptoms can include indigestion or heartburn, pain or discomfort in
the abdomen, nausea and vomiting, bloating of the stomach after meals and loss
of appetite. Signs of more advanced G/GEJ cancer can include unexplained weight
loss, weakness and fatigue, and vomiting blood or having blood in the stool.
Risk factors associated with gastric and GEJ cancer can include older age, male
gender, family history, H. pylori infection, smoking, and gastroesophageal
reflux disease (GERD). Because early-stage gastric cancer symptoms frequently
overlap with more common stomach-related conditions, G/GEJ cancer is often
diagnosed in the advanced or metastatic stage, or once it has spread from the
tumor’s origin to other body tissues or organs. The five-year relative survival
rate for patients at the metastatic stage is 8.1%.5
Important
Safety Information
For
important Safety Information for VYLOY, submit your inquiry through our webform
- https://www.astellas.com/in/medicines-information-submission
About
Astellas
Astellas
is a global life sciences company committed to turning innovative science into
VALUE for patients. We provide transformative therapies in disease areas that
include oncology, ophthalmology, urology, immunology and women's health.
Through our research and development programs, we are pioneering new healthcare
solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
"This
press release is issued by Astellas Pharma India Private Limited solely for the
purpose of providing factual information to accredited media representatives
and registered healthcare professionals. It is not intended as, and shall not
be construed as, an advertisement to the general public within the meaning of
the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, or the
Drugs and Cosmetics Act, 1940. VYLOY™ (zolbetuximab) is a prescription-only
medicine approved by the Central Drugs Standard Control Organization (CDSCO),
India, and must only be prescribed and administered by qualified medical
professionals. Nothing in this press release shall be construed as a guarantee
or representation regarding therapeutic outcome, cure, or efficacy in any
individual patient."
Astellas
Cautionary Notes
In this press release, statements made with respect to current plans,
estimates, strategies and beliefs and other statements that are not historical
facts are forward-looking statements about the future performance of Astellas.
These statements are based on management's current assumptions and beliefs in
light of the information currently available to it and involve known and
unknown risks and uncertainties. A number of factors could cause actual results
to differ materially from those discussed in the forward-looking statements.
Such factors include, but are not limited to: (i) changes in general economic
conditions and in laws and regulations, relating to pharmaceutical markets,
(ii) currency exchange rate fluctuations, (iii) delays in new product launches,
(iv) the inability of Astellas to market existing and new products effectively,
(v) the inability of Astellas to continue to effectively research and develop
products accepted by customers in highly competitive markets, and (vi)
infringements of Astellas' intellectual property rights by third parties.
Information
about pharmaceutical products (including products currently in development)
which is included in this press release is not intended to constitute an
advertisement or medical advice.
References:
- https://www.cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadBiologicalrDNA/CT-18%20Approvals%20Jan,%202020%20-%20march%202026.pdf
- Shitara K, Lordick F, Bang YJ, et al.
Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive,
HER2-negative, untreated, locally advanced unresectable or metastatic
gastric or gastro-esophageal junction adenocarcinoma (SPOTLIGHT): a
multicenter, randomized, double-blind, phase 3 trial. Lancet
2023;401(10389):1655-1668. Errata in: Lancet 2023;402(10398):290; Lancet
2024;403(10421):30.
- Shah MA, Shitara K, Ajani JA, et al.
Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal
junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med
2023;29(8):2133-2141.
- https://gco.iarc.who.int/media/globocan/factsheets/populations/356-india-fact-sheet.pdf
- National Cancer Institute. Cancer Stat
Facts: Stomach Cancer. 2025. Accessed at
https://seer.cancer.gov/statfacts/html/stomach.html on December 9, 2025.
- https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230018C