FDA Grants Adcetris a Breakthrough Therapy Designation for Rare Lymphoma

The Food and Drug Administration (FDA) granted a breakthrough therapy designation to Adcetris (brentuximab vedotin) for the frontline treatment of certain lymphoma subtypes, according to Seattle Genetics, the manufacturer of the antibody-drug conjugate.

The designation is for patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with the three-drug combination CHP (cyclophosphamide, doxorubicin and prednisone).

PTCL is a rare type of non-Hodgkin lymphoma (NHL), making up about 10 percent of all NHL cases in the United States.

The FDA’s decision was based on results from the phase 3 ECHELON-2 study, which will have updated results presented at the American Society of Hematology (ASH) Annual Meeting, held from Dec. 1-4, in San Diego. The trial is a randomized, double-blind, placebo-controlled trial designed to compare Adcetris plus CHP to the CHOP regimen (cyclophosphamide, doxorubicin, vincristine and prednisone).

“Data from the ECHELON-2 phase 3 trial of Adectris in combination with chemotherapy showed superior progression-free survival and overall survival versus the standard of care chemotherapy regimen, CHOP, in the treatment of frontline CD30-expressing peripheral T-cell lymphomas,” Clay Siegall, Ph.D., president and CEO of Seattle Genetics, said in a statement.

The trial met its primary endpoint, proving that there was a statistically significant improvement in progression-free survival (PFS) in patients who took Adcetris plus CHP compared to those on the CHOP regimen. The Adcetris arm also demonstrated better overall survival, according to Seattle Genetics.

Adcetris is an antibody-drug conjugate that targets CD30, a protein that is present in multiple types of PTCL. Side effects included peripheral neuropathy, anaphylaxis and infusion reactions, hematologic toxicities, infections, tumor lysis syndrome, increased toxicity for those with kidney impairments, hepatoxicity, progressive multifocal leukoencephalopathy, pulmonary toxicity, skin reactions, gastrointestinal complications and embryo-fetal toxicity for women who are pregnant.

“This is the third breakthrough therapy designation for Adcetris and supports our goal to make this therapy available to patients with newly diagnosed peripheral T-cell lymphomas as soon as possible. We look forward to presenting the data from our phase 3 ECHELON-2 trial at the upcoming ASH Annual Meeting,” said Siegall.