Adcetris (Brentuximab Vedotin) Approved For Hodgkin Lymphoma And Systemic Anaplastic Large Cell Lymphoma - FDA

The FDA has approved brentuximab vedotin, brand name Adcetris, for the treatment of HL (Hodgkin lymphoma) and ALCL (systemic anaplastic large cell lymphoma). Adcetris consists of a drug and an antibody - an antibody-drug conjugate - the antibody directs the drug to CD30, a target on lymphoma cells.

Adectris was approved under the FDA's accelerated approval program.

Adcetris is designed for individuals whose Hodgkin lymphoma continued to progress after autologous stem cell transplant (patient's own bone marrow is used to repair damaged bone marrow after high dose chemotherapy), or after two previous treatments with chemotherapy and the patient cannot receive a transplant.

Adcetris can also be prescribed for individuals whose ALCL has progressed after one treatment with chemotherapy.

Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said:

"Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy."

Common HL symptoms include night sweats, fever, fatigue, weight loss, enlargement of the spleen and lymph nodes, according to NCI (National Cancer Institute). Approximately 8,830 new HL diagnoses will have been made by the end of this year in the USA, says NCI, and 1,300 people will have died from the disease.

Systemic ALCL is an uncommon non-Hodgkin malignant tumor that can occur in the lungs, liver, soft tissue, bones, skin, lymph nodes or some other parts of the body, say the NCI.

Adcetris is the first drug specifically indicated for ALCL patients, and the first FDA-approved treatment for HL since 1977, says the FDA.

The FDA approved Adcetris after evaluating a single-arm clinical trial with 102 participants. Patients received only Adcetris. The human study's endpoint was objective response rate - what percentage of participants' tumors either shrank or disappeared altogether after treatment. 73% of them achieved either a partial or complete response, and responded to therapy for 6.7 months (average).

The systemic ALCL single-arm clinical trial involved 58 patients. They received only Adcetris. The primary endpoint was the same; objective response rate. 86% of them achieved either a partial or complete response, and responded for 12.6 months (average).

Adcetris side effects include neutropenia (drop in white blood cells), peripheral sensoryneuropathy (nerve damage), nausea, upper respiratory infection, diarrhea, thrombocytopenia (low blood platelet levels), vomiting, and anemia.

The FDA warns that Adcetris may harm a pregnant woman's fetus.

Adcetris is marketed by Seattle Genetics of Bothell, Washington, USA.

Written by Christian Nordqvist