Cabazitaxel

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.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.

Assessment report Jevtana

Assessment report for Jevtana (cabazitaxel), Sanofi-aventis, 20 January 2011, EMA/CHMP/66633/2011.

"The Applicant has performed an ERA. According to the data provided, cabazitaxel will not result in a significant environmental impact." No data have been presented.

Assessment report Cabazitaxel Accord

Assessment report for Cabazitaxel Accord, Accord Healthcare S.L.U., 30 April 2020, EMA/267872/2020.

No Environmental Risk Assessment (ERA) studies were submitted. The applicant argued that the product is unlikely to increase overall cabazitaxel use or environmental exposure. However, this justification was considered insufficient, and a post-authorisation assessment of predicted environmental exposure was recommended. No such data were found during a search of the EMA website conducted on 6 July 2026.

Comment on generics

After the implementation of the latest European Medicines Agency (EMA) ERA guideline (1 September 2024), a generic company has the following options for Article 10 procedures under Directive 2001/83/EC:

i) to argue that a full ERA is not required because the pharmaceutical substance belongs to certain substance groups (e.g., so-called natural substances);

ii) to identify an official ERA from a previously accepted product and use it; or

iii) to develop its own ERA according to the latest EMA ERA guideline.

Arguments for not submitting an Environmental Risk Assessment (ERA) based on the claim that total environmental exposure has not increased (via total sales volumes) belong to the previous ERA guideline system (2006–2024) and are no longer applicable. Regarding option ii), it should be noted that if a reference ERA exists, the generic company must demonstrate that its conclusions remain technically relevant (since the latest ERA guideline introduced several new technical requirements absent in the previous ERA guideline) and in terms of exposure (showing that the estimated exposure used in the reference ERA remains reasonable). Regulatory authorities (national and EMA) recommend that generic companies attempt to obtain reference ERA documentation from other companies via a so-called Letter of Access (LoA). However, if this is not possible, it remains feasible to argue that the conclusions of an existing reference ERA are still relevant based on information gathered from public assessment reports (summarized descriptions of environmental risk assessments) and product information (to confirm that dosages, indications, etc., have not changed). It should be noted that in some cases, reference ERAs approved between 2006 and 2024 may need to be modified (e.g., with additional experimental studies). If no previous reference ERA can be identified or used, the generic company must commit to developing its own ERA.

Fass environmental information

Fass environmental information for Jevtana (retrieved on 2026-07-06).

Excretion (metabolism)

"Cabazitaxel is excreted to 2.3 % as parent compound and to 76 % as metabolites ... Metabolites identified are around 20 ... The pharmacological activity of the metabolites is not known."

Hazard

Persistence: Results from an OECD 301B test showed that cabazitaxel degraded by 17.76% after 28 days. As the substance does not meet the criteria for ready biodegradability, cabazitaxel is considered potentially persistent in the environment.

Bioaccumulation: Log P_ow = 3.78 at pH 7 (guideline OECD 107).

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC 21 days for crustacean (Daphnia magna) 8.9 microg/L.

Risk

PEC/PNEC is based on total sold amount API (active pharmaceutical ingredient) in Sweden year 2024.

PEC = 1.5*10 microg/L.

PNEC = Lowest NOEC, 8.9 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.89 microg/L.

PEC/PNEC = 1,7*10^-5, which gives the risk insignificant.