The US Food and Drug Administration (FDA) has accepted for filing Seattle Genetics’ supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. Additionally, the agency granted Priority Review for the application.
The agency is set to make a decision on whether to expand approval of the drug by August 18.
The company submitted the supplemental BLA based on positive results from a late-stage clinical trial, known as AETHERA. The Phase III trial was designed to determine if 16 cycles of Adcetris as consolidation therapy immediately following an autologous stem cell transplant (ASCT) could extend progression-free survival (PFS) in HL patients at high risk of relapse or progression. In the Phase III trial, the drug achieved its primary endpoint of PFS, with a median PFS of 43 months for patients who received Adcetris versus 24 months for patients who received placebo. Additionally, patients treated with Adcetris received a median of 15 treatment cycles and 48 percent received the maximum of 16 cycles, indicating generally acceptable tolerability and a manageable adverse reaction profile.
Adcetris is an antibody drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes. The drug is already approved in relapsed HL and sALCL.
According to the company, there are more than 65,000 cases of HL diagnosed each year worldwide. While frontline combination chemotherapy can result in durable responses, up to 30 percent of these patients relapse or are refractory to frontline treatment. Currently, the standard for these patients is to proceed to an ASCT but roughly half of all HL patients who undergo an ASCT experience subsequent disease relapse.
“The FDA’s filing of our supplemental BLA and priority review designation for Adcetris as consolidation therapy represents a significant milestone towards our goal of making Adcetris available to high risk HL patients immediately following an autologous stem cell transplant who currently have no therapeutic options to prevent progression,” said Clay B. Siegall, PhD, President and Chief Executive Officer of Seattle Genetics. “The phase 3 AETHERA trial demonstrated that using Adcetris in this setting significantly improved progression-free survival with a manageable safety profile. We look forward to working with the FDA during their review of our application for approval of this additional indication for Adcetris.”