The FDA has approved the use of brentuximab (Adcetris, made by Seattle Genetics) to treat Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL).

Adcetris is an antibody-drug conjugate, allowing the antibody to target CD30 cells. The approval is for use in patients with Hodgkin lymphoma whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant; and for patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

"Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy," said Richard Pazdur, MD, Director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

Systemic ALCL is a rare NHL that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs, or liver.

The drug is the first new FDA-approved treatment for Hodgkin lymphoma since 1977 and the first specifically indicated to treat ALCL.

The most common side effects experienced with Adcetris have been neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia.

The approval warns that pregnant women should be cautioned that Adcetris might cause harm to their unborn baby.