FDA, Market

Inching closer to blockbuster status, Seattle Genetics gets fourth FDA win for Adcetris

Seattle Genetics $SGEN has bagged another approval for its flagship therapy Adcetris — now the fourth indication for the cancer drug.

The FDA approved Adcetris (brentuximab vedotin) to treat the most common subtypes of cutaneous T-cell lymphoma: primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF). The green light came more than a month before the PDUFA date.

Clay Siegall

Approval for the drug was based on a Phase III study comparing Adcetris dosed every three weeks versus standard care options methotrexate or bexarotene. The trial met its primary endpoint with Adcetris showing a “highly statistically significant improvement” in the rate of objective response lasting at least four months (56.3%) compared to the control arm (12.5%).

Seattle Genetics controls the US and Canadian markets for Adcetris, with its partner Takeda taking on the rest of the world. Now with its fourth approval, Adcetris could bring meaningful revenue to the company.

Earlier this year, Seattle Genetics’ CEO Clay Siegall told Endpoints News that he has high hopes the drug will be a core revenue driver.

“We think Adcetris has an excellent chance of being a billion-dollar drug in the US,” the CEO said in July.

With more trials in the pipeline, time will soon tell.



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