FDA Gives Accelerated Approval to Lymphoma Drug

(National Institutes of Health)

The U.S. Food and Drug Administration approved the drug Adcetris (brentuximab vedotin) developed by Seattle Genetics of Bothell, Washington, to treat two types of lymphoma. FDA approved Adcetris under an accelerated review procedure for promising drugs to treat serious diseases.

Lymphoma is a type of cancer that affects the cells that play a role in the immune system, primarily those cells involved in the lymphatic system of the body. Some 35 types of lymphoma have been identified.

Adcetris treats Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). According to the National Cancer Institute, common symptoms of HL include the enlargement of lymph nodes, spleen, fever, weight loss, fatigue, or night sweats. NCI estimates that 8,830 new cases of HL will be diagnosed in the United States in 2011 and about 1,300 people will die from the disease. Systemic ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver.

Adcetris combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. Adcetris can be used in patients with HL whose disease has progressed after autologous stem cell transplant — a procedure using a patient’s own bone marrow  — or after two prior chemotherapy treatments for those who cannot receive a transplant. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

Seattle Genetics tested the drug for effectiveness specifically against each disease in separate clinical trials, on 102 HL patients and 58 systemic ALCL patients. The primary endpoint of both trials was overall response rate as assessed by an independent review facility.

The most common side effects experienced with Adcetris were a decrease in infection-fighting white blood cells (neutropenia), nerve damage (peripheral sensory neuropathy), fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels (thrombocytopenia).

FDA’s Accelerated Approval regulation allows for earlier approval of drugs to treat serious diseases and that fill an unmet medical need.  This process allows for the submission of a surrogate endpoint — a marker or indicator used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement.

Drug approvals based on surrogate endpoints are conditioned on post marketing clinical trials that verify the anticipated clinical benefits.

Read more: Trial Shows Positive Results for Hodgkin Lymphoma Drug

*     *     *