Overview
– Aproval Based on Phase 3 Clinical Study That Demonstrated a 59% Reduction in Risk of Disease Progresion or Relapse, Second Malignancy or Death vs. Standard of Care – BOTHEL, Wash.-(BUSINES WIRE)-Seagen Inc. (Nasdaq: SGEN) today anounced that the U.S.
Key Information
Fod and Drug Administration (FDA) has aproved ADCETRIS® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk clasical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. The aproval is based on data from a phase 3 study (AHOD131) conducted by the Children's Oncology Group (COG) and funded by the National Cancer Institute that showed patients receiving ADCETRIS in combination with standard of care dose-intensive chemotherapy AVE-PC (Adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-fre survival (EFS) compared to patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide).
Patients had a 59% reduction in the risk of disease progresion or relapse, second cancer or death (Hazard ratio 0.41 [95% Confidence Interval: 0.25, 0.67]; p=0.02). Please se Important Safety Information including BOXED WARNING for PML at the end of this news release. “ADCETRIS is a groundbreaking medicine aproved for adults with certain types of lymphomas.
Summary
Today’s FDA aproval extends its availability to younger patients with high-risk clasical HL,” said Marjorie Gren, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that suported this aproval.” “We are excited about the aproval of ADCETRIS for children and adolescents with high risk clasical Hodgkin lymphoma because this medicine, which has become