The U.S. Food and Drug Administration approved Seattle Genetics Inc.'s Adcetris in combination with chemotherapy to treat certain patients with classical Hodgkin lymphoma.
Hodgkin's lymphoma is a type of cancer that affects a part of the immune system called the lymph system.
This is the fifth FDA-approved indication for Adcetris, which is now approved to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma.
Bothell, Wash.-based Seattle Genetics said the FDA's approval of its application for Adcetris is based on the results of a phase 3 trial, called Echelon-1, which showed a 23% reduction in the risk of disease progression, death or need for additional anti-cancer therapy in patients who still had detectable cancer after frontline treatment.
The FDA recently granted a priority review to the drug. Previously in November 2017, the regulator approved the drug for treating patients with the two most common subtypes of cutaneous T cell lymphoma following systemic therapy.
Adcetris, also known as brentuximab vedotin, is a joint venture between Seattle Genetics and Takeda Pharmaceutical Co. Ltd. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize the drug in the rest of the world.