The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. "This approval demonstrates our commitment to approving advancements in treatment that give prescribers and patient's different options for care," said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a press release.
Brentuximab vedotin is an antibody-drug conjugate that combines an anti-C30 antibody with the drug monmethyl auristatin E, allowing the antibody to direct the drug to a target CD30 on lymphoma cells. Brentuximab vedotin was previously approved by the FDA to treat cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after failure of other treatment, and primary cutaneous ALCL after failure of other treatment.
The approval was based on a clinical trial comparing brentuximab vedotin plus conmbination chemotherapy (Adriamycin [doxorubicin], vinblastine and dacarbazine, or AVD) vs a chemotherapy-only regimen commonly used to treat cHL (AVD plus bleomycin, also known as ABVD). The trial measured modified progression-free survival (mPFS), which factors in the length of time it took for the disease to progress, death to occur, or new therapy to be started in patients who did not show a response to the treatment.
For the trial, 1,334 patients received an average of six 28-day cycles of treatment. Those treated with brentuximab vedotin plus AVD were 23% less likely to experience progression, death, or initiation of new therapy compared with those receiving ABVD. Moreover, 18% of the patients on the brentuximab vedotin–plus-AVD arm experienced disease progression, death, or began new therapy, compared with 22% of the patients on the ABVD arm.
"Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago," said Pazdur.
According to The National Cancer Institute, 8,260 people in the United States were diagnosed with Hodgkin lymphoma last year and approximately 1,070 patients with non-Hodgkin lymphoma died from the disease in 2017.