Seattle Genetics Files sBLA to FDA for Adcetris for Treatment of Hodgkin Lymphoma.
M2 PHARMA-November 3, 2017-Seattle Genetics Files sBLA to FDA for Adcetris for Treatment of Hodgkin Lymphoma
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- Bothell, Washington-based cancer treatment developer Seattle Genetics, Inc. (NASDAQ: SGEN) has submitted a supplemental Biologics License Application to the US Food and Drug Administration based on data from the phase 3 ECHELON-1 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma, the company said.
Adcetris, an antibody-drug conjugate directed to CD30, a defining marker of classical Hodgkin lymphoma, is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.
The randomized, open-label, phase 3 trial is investigating Adcetris plus AVD (adriamycin, vinblastine, dacarbazine) versus ABVD (which also includes bleomycin) as frontline therapy in patients with advanced classical Hodgkin lymphoma.
The primary endpoint is modified progression-free survival per independent review facility assessment using the revised response criteria for malignant lymphoma. Secondary endpoints include overall survival, complete remission and safety.
The multi-center trial, conducted in North America, Europe, South America, Australia, Asia, and Africa, enrolled 1,334 patients who had a histologically-confirmed diagnosis of Stage III or IV classical Hodgkin lymphoma and had not been previously treated with systemic chemotherapy or radiotherapy.
Seattle Genetics and Takeda are jointly developing Adcetris. Seattle Genetics has US and Canadian commercialization rights and Takeda has rights to commercialise Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50: 50 basis, except in Japan where Takeda is solely responsible for development costs.
Seattle Genetics develops and commercializes novel antibody-based therapies for the treatment of cancer. The company's antibody-drug conjugate technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.
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|Date:||Nov 3, 2017|
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