Sunitinib

Detailed information

Fass environmental information

Fass environmental information for Sutent (sunitinib) from Pfizer AB (retrieved on 2026-04-13).

Hazard

Persistence: Sunitinib shows limited biotic degradation. In the OECD 301B test, only about 9% mineralisation occurred, meaning the substance is not readily biodegradable. In the OECD 308 water–sediment study, degradation in the water phase was rapid, with half‑lives around 7.5 days, whereas degradation in sediment was very slow, with half‑lives between 118 and 169 days and a large proportion becoming irreversibly bound. In the wastewater treatment study (OECD 314B), no parent compound remained after 28 days; approximately 23% was mineralised and about 35% bound to sludge, with a total system half‑life of 69 hours. Abiotic degradation occurs through rapid photolysis according to OECD 316, with half‑lives between 0.5 and 1.6 days depending on pH. Because the total system half‑life in the OECD 308 study was below 12 days and photodegradation is significant, the phrase "Sunitinib is degraded in the environment" is used.

Bioaccumulation: Log D_ow = 1.03 at pH 7 (OECD 107).

Toxicity: There are data for 3 trophic levels, most sensitive fish (Fathead Minnow) NOEC 27 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021.

PEC = 1.75×10^-4 microg/L.

PNEC = Lowest NOEC, 27 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 2.7 microg/L.

PEC/PNEC = 6.48×10^-5 which gives the risk insignificant.

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.

EMA’s scientific discussion Sutent

EMA’s scientific discussion for Sutent 2007-01-10.

"Based on the estimated value of predicted environmental concentration (PEC_{surface water}) for Sutent of 0.38 µg/L phase II Environmental Effect Analysis has been performed. Both the PEC and the revised PEC are approximately 2 orders of magnitude lower than the lowest no observed effect concentration (NOEC) determined under the test conditions for various species tested. The PEC/PNEC surfacewater is determined to be 0.04. [...] Sutent does not present an environmental risk following patient use."

Assessment report Sunitinib Accord

Assessment report for Sunitinib Accord, 10 December 2020, EMA/CHMP/2430/2021.

It was justified that the introduction of Sunitinib Accord capsules is unlikely to result in any significant increase in the overall sales volumes of sunitinib‑containing products or in environmental exposure to the active substance, given the generic nature of the product. This justification was considered sufficient. No Environmental Risk Assessment studies were submitted, which was accepted because the environmental risk is expected to remain similar to that of existing sunitinib products.

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.