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Seattle Genetics Submits Supplemental Biologics License Application

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Seattle Genetics (SGEN) said Tuesday it has submitted a supplemental biologics license application (BLA) to the U.S. Food and Drug Administration based on data from the phase 3 Alcanza trial and two phase 2 investigator-sponsored trials of Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). The supplemental BLA is primarily based on positive results from the phase 3 Alcanza trial presented at the 58th American Society of Hematology annual meeting in December 2016 and published in the Lancet in June 2017.
Adcetris is currently not approved for the treatment of CTCL, the company said in a press release.

In November 2016, based on preliminary analysis of Alcanza, the FDA granted Adcetris breakthrough therapy designation for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma who require systemic therapy and have received one prior systemic therapy.