FDA approves Adcetris for first-line classical Hodgkin's lymphoma

FDA approved an sBLA from Seattle Genetics Inc. (NASDAQ:SGEN) for Adcetris brentuximab vedotin (SGN-35) in combination with chemotherapy to treat adults with previously untreated stage III or IV classical Hodgkin's lymphoma. The company said it is FDA's first approval for the first-line indication in more than 40 years. The approval comes six weeks ahead of the drug's May 1 PDUFA date.

A Seattle Genetics spokesperson told BioCentury the company plans to launch Adcetris "immediately." According to the spokesperson, the average cost per patient for a full course of first-line therapy will be about $135,000 with discounts and rebates...