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FDA Approves Brentuximab Vedotin for Previously Untreated sALCL and CD30-expressing PTCL

Approval is based on results from the ECHELON-2 study
22 Nov 2018
Haematologic malignancies;  Anticancer agents & Biologic therapy

On 16 November 2018, the US Food and Drug Administration (FDA) approved brentuximab vedotin (ADCETRIS, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.

This is the first FDA approval for previously untreated PTCL including sALCL.

Approval was based on ECHELON-2 (NCT01777152), a double-blind, multicentre trial that randomised 226 patients to brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (CHP) and 226 patients to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

Efficacy was based on independent review facility-assessed progression-free survival (PFS), defined as time from randomisation to progression, death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease.

The median PFS was 48.2 months (95% CI: 35.2, not estimable) for patients on the brentuximab vedotin plus CHP arm and 20.8 months (95% CI: 12.7, 47.6) for those on the CHOP arm (hazard ratio 0.71; 95% CI: 0.54, 0.93; p = 0.011).

The clinical trial also demonstrated improvement in overall survival (HR 0.66; 95%CI 0.46, 0.95; p = 0.024), complete response rates (68% vs 56%, p = 0.007), and overall response rates (83% vs 72%, p = 0.003).

The most common adverse reactions (incidence ≥ 20%) observed ≥ 2% more in patients receiving brentuximab vedotin plus CHP were nausea, diarrhoea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anaemia. Peripheral neuropathy occurred in 52% of patients on the brentuximab vedotin plus CHP arm and 55% on the CHOP arm.    

The recommended brentuximab vedotin dose in combination with chemotherapy for previously untreated PTCL is 1.8 mg/kg (maximum of 180 mg) every 3 weeks for 6 to 8 doses. Administer GCSF prophylaxis starting in cycle 1.

Full prescribing information for ADCETRIS is available here.

FDA used the Real-Time Oncology Review Pilot Program  for this application and was able to grant approval less than two weeks after receipt of the complete application.

FDA granted this application priority review and breakthrough therapy designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

Last update: 22 Nov 2018

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