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: 01 Dec 2017
At a glance
- Drugs Trastuzumab (Primary) ; Docetaxel; Paclitaxel
- Indications Advanced breast cancer; Male breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms HERITAGE
- Sponsors Mylan
- 01 Dec 2017 According to a Mylan media release, the U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History