- Received notification from the U.S. Food and Drug Administration (FDA) regarding the company’s supplemental Biologics License Application (sBLA). Based on ongoing interactions with the FDA, Seattle Genetics anticipates that the 16-cycle limitation on duration of use of ADCETRIS will be removed from the U.S. prescribing information. It is further anticipated that a label claim for retreatment will not be approved. Seattle Genetics intends to submit data on the use of ADCETRIS for retreatment to guidelines review committees for potential inclusion in compendia.
- Initiated a phase 1/2 clinical trial evaluating ADCETRIS in combination with bendamustine for patients with Hodgkin lymphoma (HL) after first relapse.
- Takeda received approval for ADCETRIS in South Korea through its local affiliate.
- Highlighted the ongoing phase 3 ECHELON-1 and ECHELON-2 trials at the American Society of Clinical Oncology (ASCO) annual meeting. ECHELON-1 is comparing ADCETRIS in combination with chemotherapy to standard chemotherapy for frontline HL, and ECHELON-2 is comparing ADCETRIS in combination with chemotherapy to standard chemotherapy for frontline CD30-expressing mature T-cell lymphomas (MTCL).
- Reported data in multiple sessions at the 12 th International Conference on Malignant Lymphoma, including data from an investigator-sponsored trial in salvage HL and data from a corporate trial of ADCETRIS in B-cell and T-cell non-Hodgkin lymphomas.
Seattle Genetics Reports Second Quarter 2013 Financial Results
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