Regulatory Affairs

Seattle Genetics gets FDA breakthrough therapy status for Hodgkin lymphoma treatment Adcetris

PBR Staff Writer Published 03 October 2017

Seattle Genetics has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a determining marker of Hodgkin lymphoma.

The ADC includes an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE).

Adcetris is being assessed in around 70 clinical studies, including four phase 3 studies.

The FDA has granted the status based on data from the phase 3 ECHELON-1 clinical study, which assessed a combination of Adcetris plus AVD (Adriamycin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen in previously untreated advanced classical Hodgkin lymphoma.

According to the company, the trial reached its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) of the Adcetris containing regimen versus the control arm as assessed by an independent review facility.

The randomized, open-label and phase 3 trail’s primary endpoint is modified PFS per Independent Review Facility assessment using the Revised Response Criteria for Malignant Lymphoma

Adcetris is being assessed in around 70 clinical studies, including four phase 3 studies.

The ADC includes an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE).

Seattle Genetics, along with Takeda, is developing Adcetris. As part of the deal, Seattle Genetics will have commercialization rights in the US and Canada, while Takeda will commercialize the drug in other parts of the world.

Seattle Genetics president and CEO Dr Clay Siegall said: “The phase 3 ECHELON-1 study that supports the Breakthrough Therapy Designation for Adcetris in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients.”