By: MARILYNN MARCHIONE AP Chief Medical Writer From: effinghamdailynews.com Doctors reported unusually good results from tests of two experimental drugs in women with an aggressive form of breast cancer that had spread widely and resisted many previous treatments. One drug showed particular ability to reach tumors in the brain, which are notoriously tough to treat. The other pairs a sort …
Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
From: businesswire.com Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. Results from the trial showed a 24 percent confirmed objective …
Seattle Genetics wins another speedy approval as FDA clears breast cancer drug
By: Ben Fidler From: biopharmadive.com Dive Brief: The Food and Drug Administration on Friday approved Seattle Genetics’ drug Tukysa as a treatment for patients whose advanced breast cancer expresses the HER2 protein and has spread to other areas of the body, including the brain. Approval comes four months ahead of the Aug. 20 deadline set by the FDA, a speedy …
Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Source: Seattle Genetics From: biospace.com – FDA Action Date is August 20, 2020; Application Under FDA’s Real-Time Oncology Review (RTOR) and Orbis Pilot Programs – – Supported by Results from Pivotal HER2CLIMB Trial; First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – Seattle Genetics, Inc.. (Nasdaq:SGEN) today announced that …
EMA Validates Seattle Genetics’ Marketing Authorization Application for Tucatinib for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Source: Seattle Genetics From: pipelinereview.com – Application Supported by Results of Pivotal HER2CLIMB Trial – – First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – – EU Marketing Authorization Application (MAA) Follows Recent Submission of Tucatinib New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) – …
Mitchell Cancer Institute participates in promising breast cancer drug trial
By; Lee Peck From: fox10tv.com Without question every major discovery with cancer has come on the shoulder of a clinical trial. One of those recent trials shows exciting advancement in the fight against breast cancer. The Mitchell Cancer Institute participated in this promising new trial, which was conducted around the world. Kristy Graham was one of 613 patients who participated. …
Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Source: Business Wire From: apnews.com Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients …
Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
Source: Business Wire From: apnews.comrec Seattle Genetics, Inc. (Nasdaq:SGEN) today announced completion of enrollment in the potentially pivotal innovaTV 204 phase 2 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Tisotumab vedotin is being developed in collaboration …