Trodelvy (sacituzumab govitecan)
- Region
- 🇪🇺 EU
- Active substance
- sacituzumab govitecan
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Triple Negative Breast Neoplasms
- CHMP opinion
- Thu 16 Sep 2021
- EU approval
- Mon 22 Nov 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005182
- ATC
- L01FX06
- Official record
- www.ema.europa.eu
Indication
Triple-Negative Breast Cancer Trodelvy is indicated: as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
Regulatory milestones
No milestones recorded in the last year.
Follow Trodelvy
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.