US regulators have approved the use of Seattle Genetics’ Adcetris earlier in the treatment pathway for patients with Hodgkin lymphoma.
The US Food and Drug Administration has now cleared the drug to treat patients at high risk of relapse immediately after an autologous haematopoietic stem cell transplant (HSCT), to help prevent progression of the disease.
The decision means that patients can get quicker access to Adcetris (brentuximab vedotin), as its prior approval only allowed the drug’s use after HSCT has failed.
Globally, there are more than 65,000 cases of HL diagnosed each year, and up to 30% of patients fail frontline treatment. At this point the standard is salvage therapy, followed by auto-HSCT, but around half of all HL patients who undergo an auto-HSCT experience subsequent disease relapse.
Expanded approval was based on data from the Phase III AETHERA trial which showed a significant improvement in median progression-free survival of 42.9 months for patients taking Adcetris immediately after HSCT versus 24.1 months for the placebo arm, marking an improvement of 18.8 months.
In the US, Adcetris can also be used for HL patients who are not candidates for ASCT and have failed at least two multi-agent chemotherapy regimens, and patients with systemic anaplastic large cell lymphoma after the failure of at least one multi-agent chemo regimen.
Takeda and Seattle are jointly developing Adcetris under an agreement that has given the latter commercialisation rights in the US and Canada and the Japanese drugs giant rights in the rest of the world.