Seagen’s Adcetris Gains Expanded Label for Pediatric Cancer Patients
The FDA has expanded its approval of Seagen’s Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide to treat pediatric patients two years and older with previously untreated high-risk classical Hodgkin’s lymphoma.
Adcetris is an antibody-drug conjugate that targets a specific tumor marker. The drug is also FDA-approved for adult patients with classical Hodgkin’s lymphoma at high risk of relapse or progression after stem cell transplants.
The expanded pediatric approval is based on results from a phase 3 study in which the Adcetris combination with standard of care chemotherapy had a 59 percent reduction in the risk of disease progression or relapse, second cancer or death compared to patients who received standard of care chemotherapy alone.
Adcetris first received FDA approval in 2011.