In a move that caught analysts and investors by surprise, the FDA rejected Athenex Inc.’s NDA for Oraxol, its oral version of paclitaxel, for use in metastatic breast cancer, citing safety risks and questioning the reliability of the clinical data supporting the application.
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs.
Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%.
BARCELONA, Spain – Sunday's Presidential Symposium at the 2019 Congress of the European Society of Medical Oncology was devoted to breast cancer studies, and two of those studies – MONARCH-2 and MONALEESA-3 – reported an overall survival (OS) benefit of combining a CDK4/6 inhibitor with endocrine therapy Faslodex (fulvestrant) in metastatic hormone receptor-positive (HR+) breast cancer in several different settings.
