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Seattle Genetics claims key US approval for Adcetris

Becomes the first new treatment for advanced Hl in more than 40 years

Seattle GeneticsSeattle Genetics has won FDA approval for Adcetris as a first-line treatment for advanced Hodgkin’s lymphoma, which it believes could help unlock blockbuster sales for the drug in the US alone.

Adcetris (brentuximab vedotin), an antibody-drug conjugate, is the first new treatment for this type of lymphoma in more than 40 years, with the US regulator approving it for use alongside the standard chemotherapy regimen based on the results of the ECHELON-1 trial several weeks ahead of deadline.

Shares fell slightly on the news of the approval however, with some investors apparently disappointed that the drug was not approved for a more broad use in less advanced cases of the disease. The FDA has cleared it for stage III and stage IV Hodgkin’s lymphoma only, which account for around half of all new diagnoses.

The trial measured modified progression-free survival (mPFS), the length of time it took for the disease to progress, death to occur, or new therapy to be initiated in patients who did not achieve a complete response, with Adcetris reducing that measure by 23% compared to the control group. Crucially, Adcetris avoids the use of the chemotherapy drug bleomycin, which can be associated with severe and unpredictable toxicity.

Approval in the new indication is an important pillar in Seattle’s plans for Adcetris, which made $640m in revenues last year worldwide, with some of that booked by Takeda which has rights to the drug outside the US and Canada. According to the FDA, there were around 8,260 people diagnosed with Hodgkin’s lymphoma last year.

First approved in 2011 for Hodgkin’s lymphoma patients who had failed a stem cell transplant, Adcetris has now picked up five indications. Last November it was granted FDA approval in adult patients with cutaneous T cell lymphoma (CTCL) and there is more to come.

The company is also waiting for the results of the ECHELON-2 trial of Adcetris as a first-line therapy for peripheral T cell lymphomas later this year, which could open up another market with several thousand patients diagnosed per year.

The approval is also important for Seattle after its aborted $2bn deal to license Immunomedics’ IMMU-132, another ADC drug for triple-negative breast cancer (TNBC), which was scuppered by a shareholder and claimed the jobs of Immunomedics’ CEO Cynthia Sullivan and founder David Goldberg. Seattle has since turned its attention to its own TNBC candidate ladiratuzumab vedotin.

Article by
Phil Taylor

21st March 2018

From: Regulatory



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