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Seattle Genetics' Adcetris earns FDA priority review status

The win follows a breakthrough designation from the US regulator last year

Seattle GeneticsSeattle Genetics’ Adcetris has received a boost after the US Food and Drug Administration’s (FDA) granted the lymphoma drug priority review status.

Adcetris (brentuximab vedotin), an antibody-drug conjugate, was awarded the status based on the results of the phase III ECHELON-1 trial, which had a primary endpoint of an improved PFS in previously untreated advanced classical Hodgkin lymphoma patients.

Data from the trial - which evaluated a combination of Adcetris plus Adriamycin, vinblastine, dacarbazine (ADC) - showed a 23% reduction in the risk of progression, death or need for additional therapy, achieving its primary endpoint.

Clay Siegall, president and chief executive officer of Seattle Genetics, said: “We recently reported the primary data from the phase III ECHELON-1 clinical trial in the Plenary Scientific Session of the 2017 ASH annual meeting.

“Data from the trial demonstrated superior activity of the Adcetris-containing regimen over standard of care, and we are working with the FDA to make this bleomycin-free regimen available to newly diagnosed advanced Hodgkin lymphoma patients as soon as possible.”

The priority review status follows a breakthrough therapy designation, which was granted by the US regulators October last year for the same disease indication.

Siegall added: “The FDA’s filing of our supplemental BLA with priority review represents a significant milestone in our goal to redefine the frontline treatment of advanced Hodgkin lymphoma.”

Although the current standard of care can result in ‘durable’ responses, up to 30% of patients with advanced Hodgkin lymphoma relapse or are refractory to frontline treatment.

However, the US biotech’s intravenous injection comprises of an anti-CD30 monoclonal antibody, which is designed to deliver cell-killing agents directly to cancer cells.

According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this disease.

Article by
Gemma Jones

4th January 2018

From: Regulatory

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