The US Food and Drug Administration (FDA) approved brentuximab vedotin in combination with chemotherapy for adults with previously untreated stage III or IV classic Hodgkin's lymphoma. This is the fifth FDA-approved indication for brentuximab.
The approval was based on the results of the ECHELON-1 clinical trial, which compared brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A + AVD) to doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline therapy in these patients.
The brentuximab and AVD combination represents the first clinically feasible improvement in the initial treatment of these patients, "said a study researcher at the ASH annual meeting.
"The study results represent the first successful effort in more than 30 years to improve outcomes of first-line treatment in patients with advanced HL (Hodgkin's lymphoma) without escalating the toxicity of chemotherapy to unacceptable levels," said Joseph M. Connors, MD, clinical director of the British Columbia Cancer Agency Center.
"Change has been a long time coming," suggested Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research, in a press statement.
In a press statement, researcher Connors said, "the new combination of A + AVD is remarkable in part because it removes bleomycin from the first-line treatment of these patients."
"The ECHELON-1 study results demonstrated superior efficacy of the brentuximab and chemotherapy regimen when compared to the standard of care while removing bleomycin completely from the regimen." This represents a meaningful advance for this often younger patient population, "Connors commented.
Preventive treatment with granulocyte colony-stimulating factor is recommended with brentuximab and chemotherapy for the first-line treatment of stage III or IV classic Hodgkin's lymphoma.
Brentuximab vedotin has a boxed warning that highlights the risk for John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, a rare brain infection that could cause death.
This is the fifth FDA-approved indication for brentuximab. The drug was previously approved to treat classic Hodgkin's lymphoma after relapse and classic Hodgkin's lymphoma after stem cell transplant patients at high risk for relapse or progression.
George Canellos, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, summarized the impressive results seen with brentuximab in relapsed / refractory classical Hodgkin's lymphoma.
He has also said that of the many regimens that have been tried in an attempt to improve the results seen with the current standard of care, ABVD, none have led to an improvement in overall survival.