US FDA approves Seattle Genetics' Adcetris to treat two types of lymphoma

Shares of US biotech firm Seattle Genetics Nasdaq: SGEN) gained 8% to $15.09 late Friday, after the US Food and Drug Administration approved the company’s Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). The FDA decision came 10 days earlier than expected.

Adcetris is the first new treatment for Hodgkin lymphoma in 34 years and the first specifically indicated to treat ALCL and is the first that the company will bring to the market. Seattle Genetics will commercialize the injectable drug in the USA and Canada, while Takeda (TSE: 4502) holds marketing rights for the rest of the world under an agreement with the Japanese drug major’s US subsidiary Millennium worth a potential $290 million. The drug was accepted for review by the European Medicines Agency a couple of months ago (The Pharma Letter June 28).

Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.