Seattle Genetics’ Adcetris, in combination with CHP chemotherapy, gains FDA approval for treating certain types of peripheral T-cell lymphoma.

Seattle Genetics has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its monoclonal antibody Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone). This new approval is specifically for the treatment of systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCLs) in adults, including angioimmunoblastic T-cell lymphoma and unspecified PTCLs.

The FDA’s decision is based on promising results from the phase 3 clinical trial, ECHELON-2, which involved 452 patients with various PTCLs. The trial compared the Adcetris and CHP regimen against the standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone). Results showed a significant improvement in progression-free survival for patients receiving Adcetris, averaging 48 months compared to 21 months with CHOP. Additionally, the Adcetris group exhibited better overall survival and response rates.

Adcetris Approval and Impact

Clay Siegall, President and CEO of Seattle Genetics, highlighted the swift FDA approval, achieved in less than two weeks after the submission of the supplemental Biologics License Application (BLA). Siegall emphasized the efficacy of the Adcetris regimen over the current standard of care and expressed gratitude to those involved in the ECHELON-2 trial.

Richard Pazdur, Director of the FDA’s Oncology Center of Excellence, noted that the Real-Time Oncology Review (RTOR) program facilitated the expedited approval process. By reviewing key data before the official application submission, the FDA was able to conduct a more efficient and timely review.

Adcetris targets the CD30 protein on specific cancer cells and has previously received FDA approval for treating various conditions, including adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, and systemic ALCL among others.

  Adcetris, Cancer treatment, CD30-Expressing Lymphomas, CHP Chemotherapy, Clay Siegall, ECHELON-2 Trial, FDA approval, Oncology, Peripheral T-cell lymphoma, Richard Pazdur, Seattle Genetics, US FDA, USA