BOTHELL, Wash.--(BUSINESS WIRE)--Seagen Inc. (Nasdaq:SGEN) today announced that the phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in overall survival (OS) (p=0.009) in patients with advanced classical Hodgkin lymphoma (cHL) following treatment with ADCETRIS (brentuximab vedotin) in combination with chemotherapy. With approximately six years median follow up, patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The safety profile of ADCETRIS was consistent with previous studies and no new safety signals were observed.
U.S. sanctions on Iran threaten access by some Iranians to medicines that treat diseases such as cancer and epilepsy, despite exemptions in the measures for imports of humanitarian goods, a report said on Tuesday.
Seattle Genetics has announced that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018.
ATLANTA—With full data out from a trial of Seattle Genetics’ Adcetris in advanced, first-line classical Hodgkin lymphoma, company officials are looking for a new FDA approval early next year. But at least one analyst is iffy about the treatment’s prospects.
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