Tevimbra

Tevimbra is used to treat adults with certain types of esophageal squamous cell carcinoma (ESCC), gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma that has spread (metastasized) or cannot be surgically removed.

Tevimbra's mechanism of action involves targeting and blocking PD-1, a protein found on T cells (an important cell of the immune system) that normally acts as a checkpoint to prevent T cells from attacking healthy cells. Cancer cells can exploit this checkpoint by producing signals (PD-L1) that bind to PD-1, effectively telling T cells not to attack them. By blocking PD-1, Tevimbra prevents cancer cells from using this evasion tactic. This allows T cells to recognize and attack cancer cells more effectively.

Tevimbra (generic name tislelizumab-jsgr) is an immunotherapy treatment that belongs to the drug class called checkpoint inhibitors. Tevimbra may also be called a PD-1 inhibitor.

Tevimbra first gained FDA approval on March 13, 2024.

Tevimbra is used to treat adults with:

• esophageal cancer as first-line treatment in combination with platinum-containing chemotherapy for unresectable or metastatic ESCC whose tumors express PD-L1 (≥1) as a single agent in unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
• gastric cancer as first-line treatment in combination with platinum and fluoropyrimidine-based chemotherapy for unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).
• gastric, gastroesophageal junction, or esophageal adenocarcinoma as first-line treatment in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy for HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic disease, as detected by an FDA-authorized test. You should also read the Medication Guide that comes with zanidatamab-hrii.

Your doctor will test your tumor before starting Tevimbra for a first-line indication. PD-L1 testing is used for the esophageal squamous cell carcinoma and HER2-negative gastric indications, and HER2 testing is used for the HER2-positive indication.

It is not known if Tevimbra is safe and effective in children.

To make sure Tevimbra is safe for you, tell your healthcare provider if you:

• have immune system problems such as Crohn's disease, ulcerative colitis, or lupus
• have received an organ or tissue transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barre syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Older adults

In the study of Tevimbra given with zanidatamab-hrii and chemotherapy, people aged 65 and older had more severe side effects than younger people, including more severe diarrhea and more side effects that led to death. Your healthcare provider will monitor you closely if you are in this age group.

Pregnancy

Tevimbra may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving Tevimbra and for at least 4 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if Tevimbra passes into your breast milk. Do not breastfeed while using this medicine, and for at least 4 months after your last dose.

Common side effects

The most common side effects of Tevimbra when used alone are:

• increased blood sugar levels
• decreased hemoglobin and anemia
• decreased lymphocytes
• decreased salt (sodium) levels in the blood
• decreased albumin in the blood
• increases in certain liver blood tests
• muscle and bone pain
• decreased weight
• cough
• fatigue and tiredness.

The most common side effects of Tevimbra in combination with platinum-containing chemotherapy include:

• decreased white blood cell (neutrophil) counts
• decreased salt (sodium), potassium, and calcium levels in the blood
• increased blood sugar levels
• decreased red blood cells (anemia)
• fatigue and tiredness
• decreased appetite
• increases in certain liver blood tests
• increased blood creatinine
• diarrhea
• mouth sores (stomatitis)
• vomiting.

The most common side effects of Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy include:

• nausea
• vomiting
• diarrhea
• fatigue and tiredness
• decreased platelet counts
• decreased red and white blood cells
• stomach-area (abdominal) pain
• decreased appetite
• decreased white blood cell counts
• decreased weight
• fever
• increases in certain liver blood tests
• numbness, pain, tingling, or burning in your hands or feet.

The most common side effects of Tevimbra in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy include:

• diarrhea
• nausea
• vomiting
• decreased red blood cells (anemia)
• decreased appetite
• low potassium levels in the blood
• fatigue and tiredness
• rash
• decreased white blood cell (neutrophil) counts
• decreased platelet counts
• numbness, pain, tingling, or burning in your hands or feet
• infusion-related reactions
• increases in certain liver blood tests.

Serious side effects and warnings

Tevimbra can cause the following serious side effects.

Immune system problems. Tevimbra is a medicine that may treat certain cancers by working with your immune system. Tevimbra 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. Call or see your healthcare provider right away if you develop any new or worsening symptoms, including:

• Lung problems new or worsening cough shortness of breath chest pain.
• Intestinal problems diarrhea (loose stools) or more 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 dark urine (tea colored) severe nausea or vomiting bleeding or bruising more easily than normal pain on the right side of your stomach area (abdomen).
• Hormone gland problems headaches that will not go away or unusual headaches urinating more often than usual hair loss eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness feeling more hungry or thirsty than usual.
• Kidney problems decrease in your amount of urine swelling in your ankles blood in your urine loss of appetite.
• Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or in your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with Tevimbra. Some cases of SJS and TEN have been fatal. Tell your healthcare provider right away about any severe skin reaction.

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Tevimbra. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, 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 eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• pain or burning when you pass urine, or needing to pass urine more often
• low red blood cells, bruising.

Infusion reactions that can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include: chills or shaking, dizziness, itching or rash, feeling like passing out, flushing, fever, shortness of breath or wheezing, back or neck pain.

Rejection of a transplanted organ or tissue, including a corneal graft. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ or tissue transplant that you have had.

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 Tevimbra. Your healthcare provider will monitor you for these complications.

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 Tevimbra, including blood tests of your liver enzymes, kidney function (creatinine), and thyroid function before you start and from time to time during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tevimbra if you have severe side effects.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088, or to BeOne Medicines at 1-833-969-2463.

Your healthcare provider will give you Tevimbra into your vein through an intravenous (IV) line.

• For 150 mg and 200 mg doses, the first infusion is usually given over 60 minutes. If well tolerated, later infusions can be given over 30 minutes.
• For 300 mg doses, the first infusion is given over 90 minutes, the second over 60 minutes, and later infusions over 30 minutes if each one is well tolerated.
• For 400 mg doses, the first infusion is given over 120 minutes, the second over 60 minutes, and later infusions over 30 minutes if each one is well tolerated.

Tevimbra is given every 2, 3, 4, or 6 weeks, depending on the dose your healthcare provider chooses.

• Your healthcare provider will decide how many treatments you need. Treatment usually continues until your cancer progresses or the side effects become unacceptable.
• Your healthcare provider will do blood tests to check you for certain side effects.

Tevimbra dosing information

The recommended adult dose of Tevimbra is the same across all of its approved uses, given as an IV infusion:

• 150 mg every 2 weeks, or
• 200 mg every 3 weeks, or
• 300 mg every 4 weeks, or
• 400 mg every 6 weeks.

There is no recommended dose reduction for Tevimbra. Your healthcare provider may withhold or permanently stop Tevimbra depending on the type and severity of any side effects.

If you miss any appointment, call your healthcare provider as soon as possible to reschedule your appointment.

Follow your doctor's instructions about restricting food, beverages, or activity.

Other drugs may interact with Tevimbra, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your healthcare provider will store Tevimbra in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light.

Do not freeze. Do not shake.

Active: tislelizumab-jsgr

Inactive ingredients: citric acid monohydrate, histidine, L-histidine hydrochloride monohydrate, polysorbate 20, sodium citrate, trehalose, and Water for Injection, USP.

Available as a 100 mg/10 mL (10 mg/mL) or 150 mg/15 mL (10 mg/mL) solution in a single-dose vial.

Tevimbra is made by BeOne Medicines USA, Inc., of Pennington, New Jersey. BeOne Medicines is the company formerly known as BeiGene, which was founded in 2010 in Beijing, China and changed its name and moved its global headquarters to Switzerland in 2025.