By: M. Alexander Otto, PA, MMS From: .medscape.com Questions are now being asked about the comparator arm of a phase 3 trial in advanced breast cancer in which the investigational drug elacestrant (developed by Menarini/Radius Health) showed enough benefit for the companies to consider applying for approval from the US Food and Drug Administration. Elacestrant is a novel oral selective estrogen …
FDA expands Enhertu approval for breast cancer
From: healio.com The FDA expanded the approval of fam-trastuzumab deruxtecan to include treatment of patients with HER2-positive metastatic breast cancer who received a prior anti-HER2-based regimen. Fam-trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 …
Olaparib Extends PFS in Ovarian Cancer in SOLO-1 Clinical Trial
By: Sarah Tilyou From: clinicaloncology.com Maintenance therapy with olaparib can reduce the risk for ovarian cancer progression and related death by 70% at three years, according to results of the phase 3 SOLO-1 trial. The findings, which were presented at the ESMO 2018 Congress (abstract LBA7_PR) and published in The New England Journal of Medicine (2018 Oct 21. [Epub ahead …
New Studies Using CELLSEARCH Circulating Tumor Cell Test to be Featured at San Antonio Breast Cancer Symposium
Research Adds to Growing Evidence of Clinical Utility of CTCs for the management of Metastatic Breast Cancer Patients Menarini Silicon Biosystems announced today that new data utilizing the company’s CELLSEARCH® Circulating Tumor Cell Test will be presented at the upcoming 2018 San Antonio Breast Cancer Symposium (SABCS). A total of 21 studies will be presented: 20 posters and an oral …
Pfizer-led consortium begins trial of metastatic breast cancer treatment palbociclib
By: PBR Staff Writer From: pharmaceutical-business-review.com Pfizer, along with Alliance Foundation Trials (AFT) and six other international cancer research groups, has commenced a phase 3 clinical study to assess palbociclib (Ibrance) for the treatment of patients with metastatic breast cancer. Ibrance is an oral inhibitor of cyclin-dependent kinase 4/6 (CDK 4/6), which triggers cellular progression. Patina is a randomized, open-label …