Results with ADCETRIS® (brentuximab vedotin) classical Hodgkin lymphoma (HL) consolidation therapy

How ADCETRIS was studied

People with classical HL were in a study where ADCETRIS therapy was compared to placebo (without ADCETRIS therapy).

  • The people in this study had classical HL with a high risk of it coming back (relapsing) or progressing after the transplant because they had one or more risk factors (please see below for more about risk factors)
  • In addition to therapy, all people in the study received best supportive care and standard therapy to prevent infection after their transplant

How was high-risk classical HL defined in the study

There are many risk factors for relapse or progression after a transplant. In the study, people were considered to have high-risk classical HL if they had one or more of the following risk factors: refractory disease, early relapse, or relapse after 12 months with extranodal disease. These risk factors increase the chance that classical HL might return or progress after stem cell transplant (SCT).

The study used risk factors for relapse or progression after SCT that were based on people’s response to frontline treatment.

When the first therapy does not work and cancer cells keep multiplying, the person’s disease is said to be refractory to therapy.

My doctor recommended ADCETRIS after SCT because my first round of chemotherapy didn’t give us the results we wanted. My HL only went into partial remission.”

*Actor portrayal, not not actual patient

When disease returns within 12 months after the first therapy, it is called an early relapse or a recurrence.

My doctor is recommending I take ADCETRIS after my SCT because, even though my HL went into complete remission with my first round of chemotherapy, it came back just 6 months later.”

*Actor portrayal, not not actual patient

When disease returns more than 12 months after first therapy and there are signs of classical HL in areas or organs outside the lymph nodes.

My doctor and I are considering ADCETRIS after my SCT, because when my HL came back it was in my chest wall as well as my lymph nodes.”

*Actor portrayal, not not actual patient

What were the study results?

People with classical HL with high risk of relapse or progression were given ADCETRIS therapy or placebo (without ADCETRIS therapy).

  • Of the 329 people studied, those who received ADCETRIS therapy had significantly less risk of relapse or progression compared with people who received placebo (this is known as progression-free survival)
  • Fewer people in the ADCETRIS group (60/165 people) had their classical HL relapse or progress during the study compared with people who received placebo (75/164 people)
  • Approximately 3 years and 7 months after starting the study, half of all people treated with ADCETRIS had not relapsed or progressed – 1 year and 7 months longer than people who received placebo

LENGTH OF TIME WITHOUT RELAPSE OR PROGRESSION AFTER START OF STUDY*†‡

  • These are median numbers, which means that half of the people had experienced relapse or progression by this time and half had not.
  • The median follow-up time was 22 months.
  • Lengths of time were rounded to the nearest whole month.

What were the side effects in the study?

The most common side effects reported by the 165 people in the study who were treated with ADCETRIS after SCT consolidation therapy are listed below.

Most common side effects*

Serious side effects

  • The most common side effects were experienced by ≥20% of patients.

The list on this page does not include all of the possible side effects of ADCETRIS therapy.

Please see Important Safety Information, including BOXED WARNING, and read full Prescribing Information.

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Important Safety Information
Important Safety Information

Indications

ADCETRIS is approved in the following settings:

  • Relapsed classical Hodgkin lymphoma (HL): Classical HL after a stem cell transplant (SCT) fails or after 2 multiagent chemotherapy regimens fail and SCT is not an option
  • Consolidation therapy in HL: Classical HL at high risk of coming back or becoming worse after SCT
  • Relapsed systemic anaplastic large cell lymphoma (sALCL): sALCL after a multiagent chemotherapy regimen fails

The effectiveness of ADCETRIS in sALCL is based on studies in which patients’ tumors became smaller. The sALCL study was not designed to show whether or not ADCETRIS could help patients live longer or feel better.

Important Safety Information

What is the Most Important Serious Safety Information I Should Know About ADCETRIS® (brentuximab vedotin) for injection?

  • Progressive multifocal leukoencephalopathy (PML): A rare but serious infection of the brain that can lead to death and can occur in ADCETRIS-treated patients. Cases occurred at different times from the start of ADCETRIS therapy, some within 3 months. Possible causes other than ADCETRIS-treatment include previous therapies and diseases that may weaken your immune system.
  • ADCETRIS should not be taken with bleomycin because of possible side effects in the lungs.

What are the Other Possible Serious Side Effects of ADCETRIS?

  • Nerve damage: Peripheral neuropathy (nerve damage) that mostly involves numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor). Symptoms increase with more doses. Your doctor may change or stop your ADCETRIS dose depending on the severity of your symptoms.
  • Allergic and infusion reactions: Allergic reactions, including severe forms, during infusion or up to 24 hours after administration of ADCETRIS. Patients who had a reaction with earlier doses should receive premedication with later doses, which may include acetaminophen, an antihistamine, and a corticosteroid.
  • Blood problems: Low number of white blood cells lasting a week or more, with or without fever. Low number of platelets (which help the blood clot) and low number of red blood cells. Your blood counts will be checked before each dose, more often if necessary. You will be monitored for fever. If your white blood cell count is too low, your doctor may delay your next infusion, lower your dose, stop your ADCETRIS therapy, or give you a medicine called growth factor with future doses of ADCETRIS.
  • Infections: Serious infections that occur when your immune system is weakened, such as pneumonia, bacteremia, and sepsis or septic shock (including deaths).
  • Tumor lysis syndrome (TLS): You will be closely monitored for TLS if you have a tumor that grows quickly or have many tumor cells throughout your body.
  • Patients with severe kidney disease: May have more side effects and deaths compared to patients with normal kidney function and should avoid use of ADCETRIS.
  • Patients with moderate or severe liver disease: May have more side effects and deaths compared to patients with normal liver function and should avoid use of ADCETRIS.
  • Liver injury: Liver problems (including deaths) have been reported after the first dose of ADCETRIS and after ADCETRIS was stopped and restarted. Your liver function will be monitored. Having liver problems, raised liver enzymes, and some medicines may increase the risk. Your doctor may delay your next infusion, lower your dose, or stop your ADCETRIS therapy if you have liver problems.
  • Lung problems: Lung problems, including deaths, have been reported. If you have symptoms, your doctor may hold your ADCETRIS therapy until they improve.
  • Skin problems: Rare but serious skin conditions (including deaths) called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If either occurs, your doctor will stop ADCETRIS and treat you for symptoms.
  • Gastrointestinal (GI) problems: Stomach and intestine problems, including deaths, have been reported. Lymphoma that involves the stomach or intestine may increase the risk of GI perforation (hole in the stomach or intestine).
  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to avoid pregnancy during, and for at least 6 months after final dose of ADCETRIS.

What Were the Most Common Side Effects in Clinical Trials?

ADCETRIS was studied by itself in 160 patients in two clinical trials in patients with relapsed classical HL and relapsed sALCL. Across both trials, the most common side effects were a low number of white blood cells, tingling or numbness in the hands or feet, feeling tired, nausea, a low number of red blood cells, an infection in the upper respiratory tract, diarrhea, fever, rash, a low number of platelets (which help the blood clot), cough, and vomiting.

ADCETRIS was studied in a trial with 329 patients with classical HL at high risk of relapse or progression after stem cell transplantation. The most common side effects in patients who received ADCETRIS (167 patients), were a low number of white blood cells, tingling or numbness in the hands or feet, a low number of platelets (which help the blood clot), a low number of red blood cells, an infection in the upper respiratory tract, feeling tired, trouble moving the hands or feet, nausea, cough, and diarrhea.

What Should I Tell My Doctor Before I Start Treatment with ADCETRIS?

  • Tell your doctor about all of your medical conditions. ADCETRIS should be avoided if you have severe kidney disease or moderate or severe liver disease or other liver problems.
  • Tell your doctor about any medicine you are taking (including over-the-counter drugs, vitamins, and herbal supplements) because it is possible for ADCETRIS to interact with certain types of drugs.
  • Tell your doctor if you are pregnant or plan to become pregnant. You should not take ADCETRIS while pregnant or breastfeeding.
  • Women should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.
  • Men with female partners should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.

Contact Your Doctor if You Experience Any of the Following:

  • Symptoms of nerve damage: Tingling, burning, or numbness in the hands or feet. Changes in sense of touch or trouble moving the hands or feet.
  • Symptoms of infection: Fever of 100.5° or higher, chills, cough, or pain upon urination.
  • Symptoms of infusion reaction: Fever, chills, rash, or breathing problems within 24 hours of infusion.
  • Symptoms of liver injury: Fatigue, anorexia, upper stomach pain, dark urine, yellowing of the skin and eyes (jaundice).
  • Symptoms of PML: Changes in mood or usual behavior. Confusion, thinking problems, or loss of memory. Changes in vision, speech, or walking. Decreased strength or weakness on one side of the body.
  • Symptoms of pancreatitis: Severe abdominal pain.
  • Symptoms of lung problems: New or worsening cough or shortness of breath.
  • Symptoms of GI problems: Severe stomach pain, chills, fever, nausea, vomiting, or diarrhea.
  • Pregnancy: Pregnant or breastfeeding women should not receive ADCETRIS.
  • Any other side effects that are bothersome or do not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-10881-800-FDA-1088.

Please see Important Safety Information, including BOXED WARNING, and read full Prescribing Information.

Important Safety Information
Important Safety Information

Indications

ADCETRIS is approved in the following settings:

  • Relapsed classical Hodgkin lymphoma (HL): Classical HL after a stem cell transplant (SCT) fails or after 2 multiagent chemotherapy regimens fail and SCT is not an option
  • Consolidation therapy in HL: Classical HL at high risk of coming back or becoming worse after SCT
  • Relapsed systemic anaplastic large cell lymphoma (sALCL): sALCL after a multiagent chemotherapy regimen fails

The effectiveness of ADCETRIS in sALCL is based on studies in which patients’ tumors became smaller. The sALCL study was not designed to show whether or not ADCETRIS could help patients live longer or feel better.

Important Safety Information

What is the Most Important Serious Safety Information I Should Know About ADCETRIS® (brentuximab vedotin) for injection?

  • Progressive multifocal leukoencephalopathy (PML): A rare but serious infection of the brain that can lead to death and can occur in ADCETRIS-treated patients. Cases occurred at different times from the start of ADCETRIS therapy, some within 3 months. Possible causes other than ADCETRIS-treatment include previous therapies and diseases that may weaken your immune system.
  • ADCETRIS should not be taken with bleomycin because of possible side effects in the lungs.

What are the Other Possible Serious Side Effects of ADCETRIS?

  • Nerve damage: Peripheral neuropathy (nerve damage) that mostly involves numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor). Symptoms increase with more doses. Your doctor may change or stop your ADCETRIS dose depending on the severity of your symptoms.
  • Allergic and infusion reactions: Allergic reactions, including severe forms, during infusion or up to 24 hours after administration of ADCETRIS. Patients who had a reaction with earlier doses should receive premedication with later doses, which may include acetaminophen, an antihistamine, and a corticosteroid.
  • Blood problems: Low number of white blood cells lasting a week or more, with or without fever. Low number of platelets (which help the blood clot) and low number of red blood cells. Your blood counts will be checked before each dose, more often if necessary. You will be monitored for fever. If your white blood cell count is too low, your doctor may delay your next infusion, lower your dose, stop your ADCETRIS therapy, or give you a medicine called growth factor with future doses of ADCETRIS.
  • Infections: Serious infections that occur when your immune system is weakened, such as pneumonia, bacteremia, and sepsis or septic shock (including deaths).
  • Tumor lysis syndrome (TLS): You will be closely monitored for TLS if you have a tumor that grows quickly or have many tumor cells throughout your body.
  • Patients with severe kidney disease: May have more side effects and deaths compared to patients with normal kidney function and should avoid use of ADCETRIS.
  • Patients with moderate or severe liver disease: May have more side effects and deaths compared to patients with normal liver function and should avoid use of ADCETRIS.
  • Liver injury: Liver problems (including deaths) have been reported after the first dose of ADCETRIS and after ADCETRIS was stopped and restarted. Your liver function will be monitored. Having liver problems, raised liver enzymes, and some medicines may increase the risk. Your doctor may delay your next infusion, lower your dose, or stop your ADCETRIS therapy if you have liver problems.
  • Lung problems: Lung problems, including deaths, have been reported. If you have symptoms, your doctor may hold your ADCETRIS therapy until they improve.
  • Skin problems: Rare but serious skin conditions (including deaths) called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If either occurs, your doctor will stop ADCETRIS and treat you for symptoms.
  • Gastrointestinal (GI) problems: Stomach and intestine problems, including deaths, have been reported. Lymphoma that involves the stomach or intestine may increase the risk of GI perforation (hole in the stomach or intestine).
  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to avoid pregnancy during, and for at least 6 months after final dose of ADCETRIS.

What Were the Most Common Side Effects in Clinical Trials?

ADCETRIS was studied by itself in 160 patients in two clinical trials in patients with relapsed classical HL and relapsed sALCL. Across both trials, the most common side effects were a low number of white blood cells, tingling or numbness in the hands or feet, feeling tired, nausea, a low number of red blood cells, an infection in the upper respiratory tract, diarrhea, fever, rash, a low number of platelets (which help the blood clot), cough, and vomiting.

ADCETRIS was studied in a trial with 329 patients with classical HL at high risk of relapse or progression after stem cell transplantation. The most common side effects in patients who received ADCETRIS (167 patients), were a low number of white blood cells, tingling or numbness in the hands or feet, a low number of platelets (which help the blood clot), a low number of red blood cells, an infection in the upper respiratory tract, feeling tired, trouble moving the hands or feet, nausea, cough, and diarrhea.

What Should I Tell My Doctor Before I Start Treatment with ADCETRIS?

  • Tell your doctor about all of your medical conditions. ADCETRIS should be avoided if you have severe kidney disease or moderate or severe liver disease or other liver problems.
  • Tell your doctor about any medicine you are taking (including over-the-counter drugs, vitamins, and herbal supplements) because it is possible for ADCETRIS to interact with certain types of drugs.
  • Tell your doctor if you are pregnant or plan to become pregnant. You should not take ADCETRIS while pregnant or breastfeeding.
  • Women should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.
  • Men with female partners should use effective birth control while taking ADCETRIS and for at least 6 months after the final dose of ADCETRIS.

Contact Your Doctor if You Experience Any of the Following:

  • Symptoms of nerve damage: Tingling, burning, or numbness in the hands or feet. Changes in sense of touch or trouble moving the hands or feet.
  • Symptoms of infection: Fever of 100.5° or higher, chills, cough, or pain upon urination.
  • Symptoms of infusion reaction: Fever, chills, rash, or breathing problems within 24 hours of infusion.
  • Symptoms of liver injury: Fatigue, anorexia, upper stomach pain, dark urine, yellowing of the skin and eyes (jaundice).
  • Symptoms of PML: Changes in mood or usual behavior. Confusion, thinking problems, or loss of memory. Changes in vision, speech, or walking. Decreased strength or weakness on one side of the body.
  • Symptoms of pancreatitis: Severe abdominal pain.
  • Symptoms of lung problems: New or worsening cough or shortness of breath.
  • Symptoms of GI problems: Severe stomach pain, chills, fever, nausea, vomiting, or diarrhea.
  • Pregnancy: Pregnant or breastfeeding women should not receive ADCETRIS.
  • Any other side effects that are bothersome or do not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-10881-800-FDA-1088.