FDA approves Adcetris + chemotherapy for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas. - Seattle Genetics

Seattle Genetics, Inc. announced a new approval for Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the FDA for adults with 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.

The approval is based on the successful outcome of the phase III ECHELON-2 clinical trial that compared Acetris plus CHP to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). The FDA granted Breakthrough Therapy designation and Priority Review to this supplemental Biologics License Application (BLA) and reviewed it under the Real-Time Oncology Review Pilot Program leading to approval less than two weeks after submission of the complete application.