Infusion solution for third-line treatment of adults with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer

About the medicinal product

Trodelvy contains the active substance sacituzumab govitecan.

Trodelvy is used to treat adults with inoperable, locally advanced or metastatic, hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer, if they have already received a hormone therapy and at least two further systemic therapies in the metastatic status and showed a progression of the disease with the last therapy.

Trodelvy was already authorised by Swissmedic on 9 September 2021 for third-line treatment of metastatic triple-negative breast cancer (mTNBC).

The indication extension for Trodelvy was authorised in connection with "Project Orbis". Project Orbis is a programme for promising cancer treatments coordinated by the FDA, the US regulatory authority. It provides a framework for the concurrent submission and review of cancer medicines by several international partner authorities in various countries. The ultimate aim is to give patients faster access to innovative cancer treatments. Currently, the authorisation authorities in Australia (TGA), Brazil (ANVISA), Canada (HC), Israel (MOH), Singapore (HSA), Switzerland (Swissmedic), and the United Kingdom (MHRA) are represented in Project Orbis.

Mode of action

Trodelvy is a cancer medicine. The active substance sacituzumab govitecan combines an antibody (a protein) that can recognise and bind to a specific receptor (Trop-2 receptor) with a substance known as a topoisomerase I inhibitor, which is effective against malignant tumours. As a result, the DNA of the tumour cells is damaged, leading to the death of the cancer cells.

Use

Trodelvy is a prescription-only medicine and is authorised as a single-dose vial containing 180 mg sacituzumab govitecan powder. The powder is dissolved in saline solution and is administered slowly into a vein.

The recommended dose is 10 mg/kg body weight once weekly. Concomitant medication can also be given to prevent infusion-related adverse reactions.

Efficacy

The efficacy of Trodelvy was investigated in trial IMMU-132-09 in 543 patients with locally advanced or metastatic HR-positive/HER2-negative breast cancer in whom the disease was advanced following treatment with at least one taxane therapy, at least one endocrine-based therapy, and at least one CDK 4/6 inhibitor (in combination with endocrine-based therapy).

The trial compared Trodelvy (272 participants) with a conventional single-substance chemotherapy chosen by the doctor (271 participants).

The median^[1] progression-free survival (PFS)^[2] was 5.5 months in the Trodelvy group compared with 4.0 months in the control group.

The median overall survival (OS)^[3] was 14.4 months in the Trodelvy group compared with 11.2 months in the control group.

The results showed a significant improvement in PFS and OS in the patients treated with Trodelvy compared to those who received conventional chemotherapy.

^[1] _{Median: the value that lies exactly in the middle of a distribution of data is called the median or central value. Half of the data values are always less than the median, the other half are always greater.}

^[2] _{Progression-free survival (PFS): period between the start of a treatment or a clinical trial and the onset of disease progression or the death of the patient.}

^[3] _{Overall survival: Overall survival refers to the period between the start of treatment and the death of the patient.}

Precautions, undesirable effects & risks

Trodelvy must not be used in those who are hypersensitive to the active substance or any of the excipients.

Nor may Trodelvy be used in certain patients with chronic inflammatory bowel disease and/or bowel obstruction or in patients requiring dialysis.

Trodelvy can cause a life-threatening lack of certain white blood cells.

Trodelvy can also cause other undesirable effects, including diarrhoea, vomiting, nausea, abdominal pain and fatigue. Complete hair loss occurs in almost half of patients.

All precautions, risks, and other possible undesirable effects are listed in the Information for healthcare professionals.

Why the medicinal product has been authorised

At the time of the application for indication extension for Trodelvy there are only limited treatment options for patients with advanced or metastatic HR-positive/HER2-negative breast cancer who are no longer responding to previous treatments.

In trials, Trodelvy showed a significant improvement in progression-free survival and overall survival in this patient group.

Although, as with other cancer treatments, the side effects of the substance can be severe, these can be managed by concomitant treatment.

Based on all the available data, the benefits of Trodelvy outweigh the risks. Swissmedic has therefore authorised the indication extension for Trodelvy in Switzerland for the treatment of advanced or metastatic HR-positive/HER2-negative breast cancer in adults, if they have already received a hormone therapy and at least two other systemic therapies in the metastatic state and showed a progression of the disease with the last therapy.

Further information on the medicinal product

Information for healthcare professionals:

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}