FDA Approves Adcetris

The U.S. Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

Highlights of Adcetris Prescribing Information

These highlights do not include all the information needed to use Adcetris safely and effectively. See full prescribing information for Adcetris.

Indications and Usage

Adcetris is a CD30-directed antibody-drug conjugate indicated for:

• The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
• The treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with Adcetris.

Dosage and Administration

• The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every 3 weeks.
• Continue treatment until a maximum of 16 cycles, disease progression or unacceptable toxicity.

Dosage Forms and Strengths

50 mg single-use vial.

Contraindications

None.

Warnings and Precautions

• Peripheral neuropathy: Treating physicians should monitor patients for neuropathy and institute dose modifications accordingly.
• Infusion reactions: If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted. If anaphylaxis occurs, the infusion should be discontinued immediately and appropriate medical management instituted.
• Neutropenia: Monitor complete blood counts prior to each dose of Adcetris. If Grade 3 or 4 neutropenia develops, manage by dose delays, reductions or discontinuation.
• Tumor Lysis Syndrome: Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome and these patients should be monitored closely and appropriate measures taken.
• Stevens-Johnson syndrome: If Stevens-Johnson syndrome occurs, discontinue Adcetris and administer appropriate medical therapy.
• Progressive Multifocal Leukoencephalopathy (PML): A fatal case of PML has been reported in a patient who received 4 chemotherapy regimens prior to receiving Adcetris.
• Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to the fetus.

Adcetris side effects

The most common adverse reactions (≥20%) are neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting.

To report SUSPECTED ADVERSE REACTIONS, contact Seattle Genetics, Inc. at 1-855-473-2436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Patients who are receiving strong CYP3A4 inhibitors concomitantly with Adcetris should be closely monitored for adverse reactions.

Use In Specific Populations

None

Patient Counseling Information

• Peripheral neuropathy Advise patients that Adcetris can cause a peripheral neuropathy. They should be advised to report to their health care provider any numbness or tingling of the hands or feet or any muscle weakness.
• Fever/Neutropenia Advise patients to contact their health care provider if a fever of 100.5°F or greater or other evidence of potential infection such as chills, cough, or pain on urination develops
• Infusion reactions Advise patients to contact their health care provider if they experience signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion.
• Pregnancy and Nursing Adcetris can cause fetal harm. Advise women receiving Adcetris to avoid pregnancy. Advise patients to report pregnancy immediately. Advise patients to avoid nursing while receiving Adcetris.