SAN DIEGO, Calif.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) today highlighted data from the ECHELON-1 phase 3 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with AVD (Adriamycin®, vinblastine and dacarbazine) in newly diagnosed stage III or IV classical Hodgkin lymphoma (HL) at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition …
Tag Archives: Hodgkin lymphoma
December, 2018
January, 2018
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2 January
FDA Grants Priority Review to Seattle Genetics’ Adcetris in Frontline Advanced Hodgkin Lymphoma
BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that the U.S. 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 …
December, 2017
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13 December
Seattle Genetics and Bristol-Myers Squibb Highlight Interim Results from Phase 1/2 Study in Hodgkin Lymphoma
ATLANTA–(BUSINESS WIRE)–Seattle Genetics, Inc. (NASDAQ:SGEN) and Bristol-Myers Squibb Company (NYSE:BMY) today highlighted updated interim results from an ongoing phase 1/2 clinical trial evaluating the combination of ADCETRIS (brentuximab vedotin) and Opdivo (nivolumab) in relapsed or refractory classical Hodgkin lymphoma (HL) at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Atlanta, …
November, 2017
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3 November
Seattle Genetics Submits sBLA to FDA for Adcetris in Frontline Advanced Hodgkin Lymphoma
BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) 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 …
October, 2017
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3 October
FDA Grants Breakthrough Therapy Designation to Seattle Genetics’ Adcetris in Frontline Advanced Hodgkin Lymphoma
BOTHELL, Wash.–(BUSINESS WIRE)–Oct. 2, 2017– Seattle Genetics, Inc. (NASDAQ:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The positive topline results of the phase 3 ECHELON-1 clinical trial …
June, 2017
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29 June
Seattle Genetics and Takeda Announce Positive Results from Late-Stage NHL Trial
CAMBRIDGE, Mass., OSAKA, Japan & BOTHELL, Wash.–(BUSINESS WIRE)–Jun. 26, 2017– Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that the Phase 3 ECHELON-1 clinical trial met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) versus the control arm. ECHELON-1 is …
March, 2017
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15 March
FDA Approves Merck’s Keytruda for Treatment of Patients with Difficult-to-Treat Classical Hodgkin Lymphoma
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who …
April, 2016
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15 April
FDA Grants Priority Review to BMS’ sBLA for Opdivo in Classical Hodgkin Lymphoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated Opdivo in cHL …
April, 2015
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20 April
FDA Accepts and Grants Priority Review to Seattle Genetics’ sBLA for Adcetris for Post-Transplant Consolidation Therapy
The US Food and Drug Administration (FDA) has accepted for filing Seattle Genetics’ supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. Additionally, the agency granted Priority Review for …