A multicentre, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules plus taxane versus Herceptin plus taxane as first line therapy in HER2-positive metastatic breast cancer
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 13 Jul 2017
At a glance
- Drugs Trastuzumab (Primary) ; Docetaxel; Paclitaxel
- Indications Advanced breast cancer; Male breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms HERITAGE
- Sponsors Mylan
- 13 Jul 2017 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings.
- 11 Jan 2017 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
- 27 Dec 2016 Results published in a Mylan media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History