Trodelvy
Authorised
This medicine is authorised for use in the European Union
sacituzumab govitecan
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Trodelvy is a medicine used to treat triple-negative breast cancer and HR-positive, HER2-negative breast cancer.
In adults with triple-negative breast cancer, Trodelvy is used on its own. In this type of cancer, the cancer cells do not have receptors (targets) for certain hormones on their surface and do not make abnormally high levels of a protein called HER2 (HER2-negative). .
Trodelvy is used in adults:
- who have not previously received systemic (whole body) treatment for metastatic cancer and who cannot have treatment with medicines known as PD-1 or PD-L1 inhibitors; it is used in adults whose cancer cannot be removed by surgery (unresectable) and is locally advanced (has spread to areas outside the breast) or metastatic (has spread to other parts of the body);
- who have had two or more prior systemic treatments, including at least one for advanced disease; it is used in adults whose cancer is unresectable or metastatic.
Trodelvy is also used for treating breast cancer when the cancer cells have receptors for certain hormones on their surface (HR-positive) and are HER2-negative. It is used in patients who have had endocrine-based therapy (hormone treatment) as well as two or more prior systemic treatments when their cancer cannot be removed by surgery or is metastatic.
Trodelvy contains the active substance sacituzumab govitecan.
The medicine can only be obtained with a prescription. It should be prescribed and given by a healthcare professional who has experience in the use of cancer medicines. It should be given in a setting where resuscitation equipment is available in case patients develop severe allergic reactions.
Trodelvy is given by infusion (drip) into a vein on day 1 and day 8 of a 3-week cycle. Treatment may be continued for as long as it remains effective and the patient does not have unacceptable side effects.
All patients should be monitored for any side effects during the infusion and for at least 30 minutes afterwards. Infusion-related reactions can be severe and, to reduce their risk, patients should be given other medicines before treatment with Trodelvy. If the patient develops infusion-related reactions, the doctor may slow down or interrupt the infusion.
For more information about using Trodelvy, see the package leaflet or contact your doctor or pharmacist.
The active substance in Trodelvy, sacituzumab govitecan, consists of two elements: a monoclonal antibody (a type of protein) that has been linked to a small molecule, SN-38. The monoclonal antibody has been designed to recognise and attach to Trop-2, a protein found on many breast cancer cells.
Once attached, the medicine is taken up by the cell where SN-38 becomes active. SN-38 blocks an enzyme (protein) called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking topoisomerase I, cancer cells are prevented from multiplying and eventually die.
Triple-negative breast cancer
Trodelvy was compared with standard treatment in one main study involving 529 patients with metastatic or locally advanced triple-negative breast cancer who received two or more prior systemic treatments, including at least one of them for advanced disease. Patients who took Trodelvy lived for a median time of 4.8 months without their disease worsening, compared with 1.7 months for the patients who took standard treatment. Patients on Trodelvy lived for a median time of 11.8 months compared with 6.9 months for patients on standard treatment.
Another main study involved 558 patients with unresectable locally advanced or metastatic triple-negative breast cancer who had not been treated for their metastatic disease before and who could not receive PD-1 or PD-L1 inhibitors. They received either Trodelvy or one of the following chemotherapies as chosen by the doctor: gemcitabine with carboplatin, paclitaxel or nab-paclitaxel.
The median time patients lived without their disease getting worse was around 9.7 months with Trodelvy compared with 6.9 months with chemotherapy. The median survival (how long patients lived) was 21.5 months with Trodelvy compared with 21.3 months with chemotherapy. The median is the point where half the patients have survived.
HR-positive, HER2-negative breast cancer
A main study compared Trodelvy to one of four commonly used chemotherapy treatments as chosen by the patients’ doctor in 543 adults with HR‑positive HER2-negative metastatic breast cancer who had received endocrine-based therapy and at least two systemic chemotherapy treatments before. Patients who received Trodelvy lived for a median time of 5.5 months before their disease got worse, compared with 4.0 months for patients who were given another treatment. Patients on Trodelvy lived for a median time of 14.4 months compared with 11.2 months for the other group of patients.
Studies carried out with Trodelvy are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Trodelvy, see the package leaflet.
The most common side effects with Trodelvy (which may affect more than 1 in 5 people) include neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), nausea, diarrhoea, tiredness, alopecia (hair loss), anaemia (low levels of red blood cells which can cause tiredness and pale skin), constipation, vomiting and decreased appetite.
Some side effects with Trodelvy can be serious. The most frequent (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell counts with fever due to infection), diarrhoea, neutropenia and pneumonia (infection of the lungs).
Trodelvy has shown meaningful improvements in overall survival in patients with metastatic triple‑negative breast cancer who received two or more prior systemic treatments, including at least one of them for advanced disease. Similar improvements were seen in how long patients lived without their disease worsening. In patient with metastatic triple-negative breast cancer who had not been treated for their disease before, Trodelvy was shown to prolong the time people lived before their disease got worse. No effect was seen on how long they lived overall in the main study; however, it was noted that half of the patients who received chemotherapy also received Trodelvy when their disease worsened which made it harder to understand the effect of Trodelvy treatment.
Trodelvy has shown meaningful improvements in heavily pre-treated patients with HR-positive HER2-negative metastatic breast cancer. Most patients in the main studies had metastatic cancer, but the European Medicines Agency considered that similar benefits could be expected in patients with locally advanced cancer that cannot be removed by surgery.
In terms of safety, although Trodelvy has important side effects compared with standard treatments, such as severe neutropenia and diarrhoea, they are considered manageable with medications and dose modifications.
The Agency therefore decided that Trodelvy’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trodelvy have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Trodelvy are continuously monitored. Suspected side effects reported with Trodelvy are carefully evaluated and any necessary action taken to protect patients.
Trodelvy received a marketing authorisation valid throughout the EU on 22 November 2021.
Product information
Latest procedure affecting product information:VR/0000312649
22/06/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Trodelvy
- Active substance
- sacituzumab govitecan
- International non-proprietary name (INN) or common name
- sacituzumab govitecan
- Therapeutic area (MeSH)
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01FX06
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Trodelvy
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