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When someone is living with advanced stomach (gastric) cancer or cancer located where the esophagus meets the stomach (gastroesophageal junction cancer, or GEJ), treatment decisions can feel especially important. Talk to your healthcare provider to learn more about biomarker testing recommendations that can help inform possible treatment options.
VYLOY® (zolbetuximab-clzb) is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum, is a first line treatment option for adults with advanced stomach/GEJ cancer when it: -cannot be removed with surgery or has spread to other parts of the body, is HER2-negative (HER2-), and tests positive for claudin (CLDN) 18.2. Vyloy is the first & only FDA-approved treatment that targets CLDN18.2 positive cancer cells. Before considering Vyloy, tell your doctor about all of your medical conditions. Vyloy may cause serious side effects including: allergic reactions, including anaphylaxis and infusion-related reactions, severe nausea and vomiting. See additional important safety information and link to prescribing information below.
Understanding Advanced Stomach and GEJ Cancer
What Is Advanced Stomach/GEJ Cancer?
Advanced gastric and gastroesophageal junction (GEJ) cancers develop when malignant cells form in the stomach lining or the area where the stomach connects to the esophagus. When the cancer spreads beyond these areas it is also known as metastatic, and it becomes more complex to treat. Yet even in these stages, advancements in medicine are offering targeted ways to slow progression—and may offer patients more moments with the people and things they love.
Understanding Biomarkers and CLAUDIN 18.2
Science has made it possible to better understand the biology of each person’s cancer. Biomarkers—specific proteins or genes—can help guide treatment decisions. Based on two global clinical studies, one such biomarker, CLDN18.2, has been estimated to be present in more than a third of advanced* stomach/GEJ cancer patients. It is one of the most common biomarkers in stomach and GEJ cancers. Claudin 18.2 is typically found in the stomach lining. When cancer develops, claudin 18.2 may become more exposed at the surface of the cancer cell. Knowing whether a tumor expresses CLDN18.2 can help a doctor determine whether a CLDN 18.2 targeted therapy is an appropriate treatment option.
How VYLOY is Thought to Work
VYLOY targets the biomarker CLDN 18.2 on stomach cancer cells. In lab studies, it has been shown that CLDN 18.2 may become exposed on the surface of these cells as cancer progresses. VYLOY binds to CLDN 18.2 and works with your immune system to help target and kill cancer cells.
Support That Goes Beyond the Medicine
Navigating cancer treatment can feel overwhelming, but you’re not alone. VYLOY Support Solutions offers access and reimbursement support to help eligible patients who have been prescribed VYLOY.
- Financial Assistance can help with potential affordability challenges, whether you have commercial prescription insurance, are uninsured or have government insurance (eg. Medicare, Medicaid)
- The Patient Connect Program helps connect you and your caregiver to resources that can provide emotional, logistical, and informational support.
Your Story Matters
Your Voice Matters
When patients share their experiences, they create ripples of encouragement. As a patient ambassador, your voice can support someone just starting their journey and offer perspective that only someone who’s been there can give. In doing so, your experience can become a bridge of knowledge for others—and a source of pride and purpose for you.
Your VYLOY Story Matters
Make a difference in the advanced stomach/GEJ cancer community by sharing your VYLOY journey.
The VYLOY Ambassador Program is here to offer insight through connections between those who’ve been there. Reach out to share your journey by emailing [email protected] or calling 1-833-605-0258.
Conclusion
The approval of VYLOY marks an evolution in the available targeted treatment options for certain patients with advanced gastric and GEJ cancers.
IMPORTANT SAFETY INFORMATION
Before receiving VYLOY, tell your healthcare provider about all of your medical conditions, including if you:
- have nausea or vomiting.
- are pregnant or plan to become pregnant. It is not known if VYLOY will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if VYLOY passes into your breast milk. Do not breastfeed during treatment with VYLOY and for 8 months after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of VYLOY?
VYLOY may cause serious side effects, including:
- Allergic reactions, including anaphylaxis and infusion-related reactions. Allergic reactions are common during treatment with VYLOY and can sometimes be serious. Serious allergic reactions can happen during or after your VYLOY infusion, including life-threatening allergic reactions and serious infusion-related reactions that may lead to death. Your healthcare provider will monitor you during your infusion and for 2 hours after or longer if needed. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction during or after your infusion of VYLOY:
- itchy, raised bumps on the skin (hives)
- coughing that does not go away
- nausea or vomiting
- stomach (abdominal) pain
- increased saliva
- breathing problems such as wheezing
- throat tightness or change in voice
- fever
- chest discomfort
- chills or shaking
- back pain
- Severe nausea and vomiting. Nausea and vomiting are common during treatment with VYLOY and can sometimes be severe. Nausea and vomiting happened more often during the first treatment cycle. Before you receive each VYLOY infusion, your healthcare provider will give you medicines to help prevent nausea and vomiting. Tell your healthcare provider right away if nausea or vomiting does not go away or gets worse.
The most common side effects of VYLOY include:
- tiredness
- decreased appetite
- diarrhea
- tingling or numbness of the arms or legs
- stomach (abdominal) pain
- constipation
- decreased weight
- fever
- decreased white blood cells, red blood cells and platelets
- decreased protein (albumin) in the blood
- changes in kidney function tests
- changes in blood sugar (glucose)
- changes in liver functions tests
- changes in body salts (electrolytes) in your blood
Your healthcare provider may slow the rate of your infusion, temporarily stop, or completely stop treatment with VYLOY if you have certain side effects. These are not all of the possible side effects of VYLOY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indication
What is VYLOY?
VYLOY is a prescription medicine used to treat adults with cancer of the stomach (gastric cancer) or cancer located where the esophagus joins the stomach (gastroesophageal junction cancer). VYLOY is used in combination with chemotherapy that contains fluoropyrimidine and platinum as the first treatment when your gastric or gastroesophageal junction cancer:
- cannot be removed with surgery or has spread to other parts of the body,
- is HER2-negative, and
- your tumor tests positive for “claudin (CLDN)18.2.”
It is not known if VYLOY is safe and effective in children.
Please see full Prescribing Information, including Patient Information For VYLOY (zolbetuximab-clzb).
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