Comparative PK, Efficacy, Safety and Immunogenicity evaluation of Bmab-200 versus Herceptin, both in combination with Docetaxel in patients with Her2+ Metastatic Breast Cancer: A Double Blind, Randomised, Active Control, Parallel assignment, Comparative Phase III, Clinical Trial
Phase of Trial: Phase III
Latest Information Update: 01 Dec 2017
At a glance
- Drugs Trastuzumab (Primary) ; Docetaxel
- Indications Advanced breast cancer
- Focus Pharmacokinetics; Registrational
- Sponsors Biocon
- 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.
- 18 Jan 2012 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India.