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Seattle Genetics wins FDA approval to expand use of lymphoma treatment

Last updated: 15:39 18 Aug 2015 BST, First published: 13:39 18 Aug 2015 BST

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Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes.

Seattle Genetics (NASDAQ:SGEN) advanced in early New York trading after the biotechnology company won approval to expand the use of its Adcetris treatment.

Shares were up 2.9% at $47.80. The stock had closed up 5.6% on Monday expanding this year’s rally to 45%.

The U.S. Food and Drug Administration (FDA) has approved Adcetris for the treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, the Bothell, Washington-based company said in a statement late Monday.

The approval is based on a phase 3 clinical trial called Aethera that was designed to compare up to 16 cycles (approximately one year) of Adcetris therapy administered every three weeks following auto-HSCT to placebo. 

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes. 

“With this FDA approval, Adcetris is the first and only consolidation treatment option available to high risk classical Hodgkin lymphoma patients who undergo a transplant to preserve their post-auto-HSCT remissions,” Clay Siegall, chief executive officer of Seattle Genetics, said in the statement. 

“This represents a meaningful advance for cancer patients and an important milestone for the Adcetris development program,” he added.

“Together with our three ongoing phase 3 trials and more than 30 additional clinical trials, this approval supports our goal to broadly establish Adcetris as the foundation of therapy for classical Hodgkin lymphoma and CD30-expressing malignancies.”

Globally, there are more than 65,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable responses, up to 30 percent of these patients fail frontline treatment. The standard for these patients is salvage therapy, followed by auto-HSCT; approximately half of all Hodgkin lymphoma patients who undergo an auto-HSCT experience subsequent disease relapse.

 

 

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