(SGEN) Seattle Genetics’ Adcetris under FDA Review

Seattle Genetics, Inc. (SGEN) recently announced that the US Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) seeking approval of Adcetris (brentuximab vedotin) for an additional indication. The company is looking to get Adcetris approved for retreatment and extended duration of medication with the drug beyond 16 cycles in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). We remind investors that Seattle Genetics submitted the sBLA to the FDA in Mar 2013 on the basis of encouraging data from a phase II study. The study had two treatment arms. One arm evaluated retreatment with Adcetris in patients who had responded to Adcetris treatment earlier, then discontinued treatment and as a result suffered disease progression or relapse. The other arm evaluated prolonged treatment