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FDA grants regular approval to brentuximab vedotin in untreated Hodgkin lymphoma

March 21, 2018—Yesterday, the U.S. Food and Drug Administration (FDA) approved the use of brentuximab vedotin, a CD30-targetted antibody-drug conjugate, in combination with chemotherapy for the treatment of adult patients with previously untreated stage III/IV classical Hodgkin lymphoma (cHL).
 
This approval is based on findings from the phase III ECHELON-1 trial (NCT01712490), in which patients were randomized to receive brentuximab vedotin or bleomycin in combination with the chemotherapy triplet of doxorubicin, vinblastine, and dacarbazine.
 
Efficacy was established based on modified progression-free survival (mPFS), defined as progression, death, or the need for additional anticancer therapy in patients who failed to achieve a complete response following frontline therapy. The estimated median mPFS was not reached in either arm, with a median follow-up of 24.6 months. In the study, patients randomized to the brentuximab vedotin arm had a reduced risk of progression, death, or initiation of a new therapy of 23% compared with patients randomized to the control arm. Data presented by Connors and colleagues at the 2017 ASH Annual Meeting and Exposition showed the 2-year mPFS rate was 82.1% with brentuximab vedotin compared with 77.25% for standard chemotherapy. At the time of the mPFS analysis, an interim overall survival analysis did not demonstrate a significant difference between the two arms.
 
This approval follows a breakthrough therapy designation granted to frontline brentuximab vedotin in October 2017. This approval also converts the accelerated approval granted for adults with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one multiagent chemotherapy regimen to a regular approval.
 
Adverse event profiles were consistent with known toxicities of the single agents. Grade 3 or higher infections were more commonly observed in the brentuximab vedotin arm (18%) than the control arm (10%). Neutropenia was reported in 58% of patients who randomized to the brentuximab vedotin arm compared with 45% randomized to the control.
 
Brentuximab vedotin is also approved for the treatment of adult patients with cHL at high risk of relapse or progression following autologous hematopoietic stem cell transplantation (HSCT), after failure of autologous HSCT, or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not eligible for HSCT. Brentuximab vedotin is also approved for systemic ALCL for the indication described above and for primary cutaneous ALCL or CD30­expressing mycosis fungoides who have received prior systemic therapy.
 
Full prescribing information of brentuximab vedotin can be found here.
 
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Jonathan A. Bell
Published Online: Wednesday, March 21, 2018


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