Table 2.
Timeline approval of trastuzumab in different formulations and indications by FDA and EMA (1, 2)
| Formulation | Date of approval | |
|---|---|---|
| FDA | EMA | |
| IV TZB mBC | September 1998 | August 2000 |
| IV TZB eBC | November 2006 | May 2006 |
| IV TZB mGEJaC | October 2010 | December 2009 |
| SC TZB mBC | NA | June 2013 |
| SC TZB eBC | NA | June 2013 |
| SC TZB mGEJaC | NA | NA |
eBC early breast cancer, EMA European Medicines Agency, FDA US Food and Drug Administration, IV intravenous, mBC metastatic breast cancer, mGEJaC metastatic gastric or gastroesophageal junction adenocarcinoma, NA non-approved, SC subcutaneous, TZB trastuzumab