Seagen’s plan to expand Adcetris’ market is on track following positive Phase II study results. Monday, the biopharma announced Adcetris hit the mark in a multi-part, midstage trial for advanced and early-stage classical Hodgkin lymphoma (cHL).
The shuttering of Teva’s long troubled manufacturing facility in Irvine, California, may create shortages of up to 24 generic sterile injectable drugs, including five essential medications of which the company supplied more than 15% of the market last year, according to an industry group.
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.
BOTHELL, Wash.--(BUSINESS WIRE)--Seagen Inc. (Nasdaq:SGEN) today announced promising efficacy and safety results from Part B of an open-label, phase 2 clinical trial evaluating ADCETRIS® (brentuximab vedotin) in a novel combination with nivolumab, doxorubicin, and dacarbazine (AN+AD) as a frontline treatment for patients with advanced stage classical Hodgkin lymphoma (cHL). Data from this preliminary analysis were presented (Abstract #2454) as part of a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta.
Enforcement Report - Week of March 3, 2021
ADCETRIS in Combination with AVD (Adriamycin, Vinblastine and Dacarbazine) Demonstrated 29-Percent Reduction in the Risk of Progression, Death or Need for Additional Anticancer Therapy for CD30+ Stage IV Patients
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.
FDA approves Eisai`s drug Halaven for type of soft tissue cancer
Array BioPharma Inc said its experimental drug helped patients with a form of skin cancer live longer without their cancer progressing, in an ongoing late-stage study.