Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On November 10, 2022, the FDA approved brentuximab vedotin brand name Adcetris in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.
Efficacy was evaluated in a randomized, open-label, actively controlled trial. High risk was identified as Ann Arbor Stage IIB with bulk disease, Stage IIIB, Stage IVA, and Stage IVB. Of the 600 total patients randomized, 300 were randomized to brentuximab vedotin plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide, and 300 patients were randomized to doxorubicin plus bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. The main efficacy outcome measure was event-free survival, defined as the time from randomization to the earliest of disease progression or relapse, second malignancy, or death due to any cause. Median event-free survival was not reached in either arm. There were 23 events in the brentuximab vedotin arm and 52 events in the control arm with a corresponding hazard ratio of 0.41.
The most common Grade 3 or greater adverse reactions occurring in more than 5% of pediatric patients treated with brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at Drugs@FDA: FDA-Approved Drugs.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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