FDA Approves Brentuximab Vedotin for 2 Types of Lymphoma

On Friday, the FDA announced that brentuximab vedotin (Adcetris) has been approved for the treatment of Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). In July, the drug had been unanimously recommended for accelerated approval by the FDA’s Oncologic Drug Advisory Committee.

Brentuximab vedotin is an antidrug conjugate containing an anti-CD30 monoclonal antibody. The drug selectively targets CD30, an important genetic marker in classic lymphoma and anaplastic large cell lymphoma, while sparing nearby normal cells that do not express the marker. It has been approved to treat HL in patients who have relapsed after receiving autologous stem cell transplant therapy and in patients with sALCL who have relapsed after undergoing at least 1 prior chemotherapy treatment.

It is the first new FDA-approved treatment for HL since 1977 and the first approved specifically for the treatment of ALCL.

“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, in a statement released on Friday.

Richard Pazdur, MD

Image courtesy of ASCO

A number of prominent studies have confirmed the effectiveness of brentuximab vedotin. Results of a study that involved patients who had previously undergone autologous stem cell transplantation were presented at the American Society of Hematology meeting in 2010. Of the 102 patients enrolled in the study, 75% exhibited some kind of demonstrated response, defined as showing tumor shrinkage of 50% or more. Complete remission was achieved by 34% of patients in the study. Overall, 94% of patients experienced some form of tumor regression.

Another study was presented at the European Hematology Association meeting in June 2011. The phase II study found that 14 of the 15 patients (93%) achieved complete remission of their cutaneous lesions, a side effect of lymphoma, after a median of 14.9 weeks of treatment with brentuximab vedotin. An independent central review further revealed that all 15 patients achieved the objective response to their systemic disease, and 13 of the 15 patients achieved complete remission. The remaining 2 patients achieved partial remission.

Some side effects experienced by the patients in the studies included peripheral sensory neuropathy, fatigue, nausea, upper respiratory tract infection, and diarrhea. The most common adverse events of at least grade 3 were neutropenia, peripheral sensory neuropathy, thrombocytopenia, and anemia. In the study presented at ASH, 20% of patients discontinued brentuximab vedotin because of treatment-related adverse affects. The study authors reported that none of the deaths of patients enrolled in the study were attributable to brentuximab vedotin.

According to the American Cancer Society, of the approximately 8800 cases of Hodgkin lymphoma projected to be diagnosed in 2011, 30% of those patients are expected to be relapsed or refractory Hodgkin lymphoma.