Seattle Genetics’ star cancer drug Adcetris has won Food and Drug Administration approval for treatment of a fast-growing type of non-Hodgkin lymphoma. The approval comes after the drug showed better results in patients than the standard treatment for the cancer.
This is the first time the FDA has approved a drug for treatment of newly diagnosed peripheral T-cell lymphoma (PTCL), and it did so in under two weeks. That’s light speed for an agency which typically takes one to two years to approve a new drug application.
PTCL is a rare yet aggressive kind of non-Hodgkin lymphoma that develops from white blood cells called T-cells.
Seattle Genetics CEO Clay Siegall credited the FDA’s new Real-Time Oncology Review program for approval in “an unprecedented less than two weeks after submission” of the application. Under the pilot program, which began issuing approvals in July, the FDA is able to review drug data prior to receiving an official application.
The combination treatment of Adcetris and chemotherapy got the thumbs-up after it demonstrated better survival rates and other outcomes than chemotherapy alone in a phase 3 clinical trial, part of Seattle Genetics’ ECHELON-2 trials. This is the sixth FDA-approved use for Adcetris, which is also a first-line treatment for classical Hodgkin’s lymphoma.
Adcetris sales in North America account for the lion’s share of revenue for Seattle Genetics, which developed the drug in partnership with Takeda in Japan. The Bothell, Wash.-based company reported in September that sales of Adcetris in the U.S. and Canada rose 54% in the first nine months of 2018, compared with the same period in 2017.
Seattle Genetics stock rose more than 6% following the announcement on Friday.