The U.S. Food and Drug Administration recently 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.
“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, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
Adcetris is the first new FDA-approved treatment for HL since 1977 and the first specifically indicated to treat ALCL.
The drug is being approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug’s clinical benefit.
Adcetris is marketed by Seattle Genetics of Bothell, Wash.
Source: U.S. Food and Drug Administration, USA