Sacituzumab govitecan

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

Assessment report Trodelvy 2021

Assessment report for Trodelvy (sacituzumab govitecan), Gilead Sciences Ireland, 14 October 2021, EMA/623887/2021.

Sacituzumab govitecan is an antibody-drug conjugate consisting of a Trop-2-targeting monoclonal antibody linked to SN-38, a topoisomerase I inhibitor, via a cleavable linker.

The antibody component and linker were not considered to pose a significant environmental risk. SN-38 was identified as the environmentally relevant component. SN-38 had a log P value below the trigger for further PBT screening, and the calculated surface water PEC was below the action limit of 0.01 microg/L. Therefore, no further Phase II environmental assessment was considered necessary.

Assessment report Trodelvy 2023

Assessment report for Trodelvy, Gilead Sciences Ireland, type II variation for extended indication, 22 June 2023, EMA/319185/2023.

No updated environmental risk assessment was submitted. The previously approved environmental risk assessment for sacituzumab govitecan was considered applicable, as the new indication was not expected to increase environmental exposure. The PEC for SN-38 remained below the action limit of 0.01 microg/L. Sacituzumab govitecan was therefore not expected to pose a risk to the environment.

Assessment report Trodelvy 2026

Assessment report for Trodelvy, Gilead Sciences Ireland, type II variation for extended indication, 21 May 2026, EMADOC-1700519818-3239527.

The previous environmental risk assessment was considered applicable. As the dosing regimen remained unchanged for the new indication, environmental exposure was not expected to increase and no updated environmental risk assessment was therefore considered necessary. This was considered acceptable.

Fass environmental information

Fass environmental information for Trodelvy from Gilead (retrieved on 2026-08-21).

Sacituzumab govitecan was considered unlikely to pose a significant environmental risk. The antibody component is expected to degrade rapidly in the environment, while SN-38 was identified as the environmentally relevant component. SN-38 had a reported log K_ow value of 2.65, which is below the trigger value for further PBT screening. In addition, the PEC for SN-38 was below the EMA action limit (0.01 microg/L). Therefore, no further environmental studies were considered necessary.