Seattle Genetics Inc. (SGEN) Friday announced that FDA has granted accelerated approval for Adcetris (brentuximab vedotin).
Adcetris has been approved for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. It has been also approved for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years. Seattle Genetics expects to make Adcetris available to patients next week.
"Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer," said Chief Executive Clay Siegall.
The recommended dose of Adcetris is 1.8 milligrams per kilogram administered only as an intravenous infusion over 30 minutes every three weeks. Treatment should be continued until a maximum of 16 cycles, disease progression or unacceptable toxicity.
SGEN is currently trading at $14.50, up $0.55 or 3.94%, on a volume of 3.2 million shares.
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