These definitions can help you better understand the language used to describe advanced bladder cancer and BAVENCIO.
Antibody: A protein made by the body’s white blood cells as part of your immune system. Antibodies respond to antigens, a substance that triggers an immune response in your body, to help destroy them.
Antibody-drug conjugate: A substance made of monoclonal antibody that is attached to a drug. The monoclonal antibody can bind specific proteins on certain types of cells, like cancer cells, to enter the cell and kill them without harming other cells.
Bladder cancer: Cancer that forms in tissues of the bladder, most commonly urothelial cancer.
Chemotherapy: A type of treatment that uses drugs to stop the growth of cancer cells by killing them or stopping the cells from dividing. Chemotherapy can be given by mouth, injection, infusion, or on the skin. It can be given alone or with other treatments like surgery, radiation therapy, or biologic therapy.
Clinical trials: A type of research study that tests how well a new treatment, like a medicine, different approach, or test, works in people.
Cystoscopy: This exam looks at the bladder and urethra using a cystoscope. A cystoscope is a thin instrument that looks like a tube with a light and lens at the end. It is used to look inside your body and remove some tissue if needed.
First-line therapy: The first treatment given for a disease, often part of a set of treatments like surgery followed by chemotherapy and radiation. It can be considered the best treatment when used alone. BAVENCIO is a first-line maintenance treatment for advanced bladder cancer.
See how BAVENCIO helps T cells attack cancer cells
Immune system: A network of cells, tissues, organs, and the substances they make that helps your body fight infections and diseases. This includes white blood cells and different tissues.
Immunotherapy: A type of therapy or treatment, like BAVENCIO, that helps your body fight cancer by affecting the immune system.
Intravenous infusion: A way to put fluids, including drugs, into the bloodstream. Also called an infusion.
Locally advanced: Cancer that spreads from where it started in the body to nearby tissue.
Lymph node: Part of your immune system, these nodes look like beans and help filter fluid and fight infections and disease with the help of white blood cells. There are hundreds of lymph nodes in the body that are connected by tubes called lymph vessels.
Maintenance therapy: A treatment given after an initial treatment, like platinum-containing chemotherapy, to help stop cancer from coming back. BAVENCIO is a first-line maintenance therapy for advanced bladder cancer.
Learn about the role of BAVENCIO in treating advanced bladder cancer
Median: The number that appears as the middle value of a set of measurements.
Metastasis: The spread of cancer cells from the place where they first formed to other parts of the body where they form a new tumor.
Overall survival: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that the patients are still alive.
PD-L1: A protein that helps the body control its immune response by stopping the body’s T cells from killing cells that have PD-L1, even if the PD-L1 is on a cancer cell. Treatments like BAVENCIO cover up the PD-L1 on cancer cells so that T cells can kill the cancer cells.
See how BAVENCIO helps T cells attack cancer cells
Platinum-containing chemotherapy: A type of chemotherapy that uses the metal, platinum, to kill some types of cancer cells.
Radiation therapy: A type of treatment that uses high-energy waves from a machine outside the body or a substance put in the body to kill cancer cells and shrink tumors.
Rash: An area on the skin that is a different texture or color and looks inflamed or irritated. It can be red, warm, scaly, bumpy, dry, itchy, swollen, or painful and may crack or blister. A rash can happen on one part of the body or all over the body.
Supportive care: Care that is given to people to help improve their quality of life during an illness or a disease by helping with the symptoms of the disease itself or side effects from a treatment. There are many types of supportive care.
Surgery: A method that is used to remove tumors from the bladder, often used in advanced bladder cancer.
T cell: A type of white blood cell that is part of your immune system and helps your body fight infections and cancer.
Targeted therapy: A type of cancer treatment that targets specific molecules that cancer cells need to survive and spread. Different targeted treatments can work in many different ways. For example, BAVENCIO targets a part of cancer cells to help your immune system attack them.
See how BAVENCIO helps your immune system attack cancer cells
Urinary tract infection (UTI): A condition when bacteria grow inside of the urinary tract, like in the kidneys, ureters, bladder, or urethra. Signs and symptoms can include pain or burning during urination, urine that is cloudy, bad smelling, or has blood in it, feeling a sudden need to urinate, pain in the back or lower abdomen, and fever, chills, or fatigue.
Urothelial carcinoma (UC): The most common type of bladder cancer. It begins in cells called urothelial cells that line the bladder and other parts of the urinary tract.
INDICATIONS & IMPORTANT SAFETY INFORMATION
Important Safety Information
Important Safety Information
BAVENCIO® (avelumab) is a medicine that may treat certain cancers by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with BAVENCIO. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with BAVENCIO if you have severe side effects.
BAVENCIO can cause serious side effects. Call or see your healthcare provider right away if you get any new or worsening signs or symptoms, including:
Lung problems
- cough
- shortness of breath
- chest pain
Intestinal problems
- diarrhea (loose stools) or more frequent bowel movements than usual
- stools that are black, tarry, sticky, or have blood or mucus
- severe stomach-area (abdomen) pain or tenderness
Liver problems
- yellowing of your skin or the whites of your eyes
- severe nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- dark urine (tea colored)
- bleeding or bruising more easily than normal
Hormone gland problems
- headache that will not go away or unusual headaches
- eye sensitivity to light
- eye problems
- rapid heartbeat
- increased sweating
- extreme tiredness
- weight gain or weight loss
- feeling more hungry or thirsty than usual
- urinating more often than usual
- hair loss
- feeling cold
- constipation
- your voice gets deeper
- dizziness or fainting
- changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems
- decrease in your amount of urine
- blood in your urine
- swelling of your ankles
- loss of appetite
Skin problems
- rash
- itching
- skin blistering or peeling
- painful sores or ulcers in mouth or nose, throat, or genital area
- fever or flu-like symptoms
- swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs or symptoms of immune system problems that can happen with BAVENCIO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
- Chest pain, irregular heartbeat, shortness of breath or swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Infusion-related reactions can sometimes be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:
- chills or shaking
- hives
- flushing
- shortness of breath or wheezing
- dizziness
- feel like passing out
- fever
- back pain
- stomach-area (abdomen) pain
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with BAVENCIO. Your healthcare provider will monitor you for these complications.
Before you receive BAVENCIO, tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- have heart problems or high blood pressure
- have diabetes
- have a high cholesterol level in your blood
- are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby
- You should use an effective method of birth control during your treatment and for at least 1 month after the last dose of BAVENCIO. Talk to your healthcare provider about birth control methods that you can use during this time
Females who are able to become pregnant:
- are breastfeeding or plan to breastfeed. It is not known if BAVENCIO passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of BAVENCIO as maintenance treatment in people with urothelial carcinoma (UC) whose cancer responded or stabilized after platinum-containing chemotherapy as first treatment include:
- feeling tired
- muscle and bone pain
- urinary tract infection
- rash
The most common side effects of BAVENCIO in people with UC after platinum-containing chemotherapy that did not work, or is no longer working, include:
- feeling tired
- infusion-related reactions including chills, fever, back pain, redness, and shortness of breath
- muscle and bone pain
- nausea
- decreased appetite
- urinary tract infection
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.
Indications
BAVENCIO is a prescription medicine used to treat:
- a type of cancer in the bladder or urinary tract called urothelial carcinoma (UC) when it has spread or cannot be removed by surgery (advanced UC). BAVENCIO may be used:
- as maintenance treatment when your cancer has responded or stabilized after you have received platinum-containing chemotherapy as your first treatment
- when you have received platinum-containing chemotherapy, and it did not work or is no longer working
It is not known if BAVENCIO is safe and effective in children under the age of 12.
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.
©2025 Merck KGaA, Darmstadt, Germany or its affiliates. All rights reserved.
EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada.
BAVENCIO, the Bavencio Connect Mentor Program, and CoverOne are registered trademarks of Merck KGaA,
Darmstadt, Germany or its affiliates.
US-AVE-01894 09/25
US-AVE-01894 09/25
This site contains medical information that is intended for residents of the United States only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Policy. This site contains information that is intended for US residents only. Canadian residents should consult the EMD Serono Canada Inc. website at www.emdserono.ca for information on products and services approved in Canada.
©2025 Merck KGaA, Darmstadt, Germany or its affiliates. All rights reserved.
EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada.
BAVENCIO, the Bavencio Connect Mentor Program, and CoverOne are registered trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.
US-AVE-01894 09/25
US-AVE-01894 09/25
This site contains medical information that is intended for residents of the United States only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Policy. This site contains information that is intended for US residents only. Canadian residents should consult the EMD Serono Canada Inc. website at www.emdserono.ca for information on products and services approved in Canada.