Solution for injection for the detection by imaging of PSMA-positive lesions in adults with prostate cancer

About the medicinal product

SWAN-PSMA-1007 is a diagnostic radiopharmaceutical^[1] containing the active substance [¹⁸F]PSMA-1007. It is administered as a solution for injection.

SWAN-PSMA-1007 contains the radioactive isotope fluorine-18. This can be used to identify PSMA-positive lesions^[2] in adults with prostate cancer with the aid of positron emission tomography (PET)^[3].

Prostate cancer is the second most frequent type of cancer in men: in 2022, there were 1.47 million diagnoses worldwide. (Source: GCO, WHO)

^[1] _{Diagnostic radiopharmaceutical: A slightly radioactive substance that is introduced into the body for the purpose of making certain tissues or diseases visible by means of imaging techniques.}

^[2] _{PSMA-positive lesions: Pathological changes in tissue that exhibit prostate-specific membrane antigen (PSMA).}

^[3] _{PET: Positron emission tomography (PET) is a body scan used to show metabolic activity in the tissue.}

Mode of action

PSMA is a protein that occurs in large amounts on the surface of most prostate cancer cells. The active substance [¹⁸F]PSMA-1007, which contains radioactive fluorine-18, binds to PSMA and thus to prostate cancer cells. By combining PET with computed tomography (PET-CT), the radioactively marked cancer cells can be visualised so that the areas within the body that are affected by prostate cancer can be identified.

Administration

SWAN-PSMA-1007 is a prescription-only medicine that is supplied as a solution for injection into the veins. The medicinal product contains the active substance [¹⁸F]PSMA-1007, the radioactivity of which is 222 MBq^[4]/mL, and is intended solely for administration in institutions that hold a permit to use radioactive substances.

The recommended dose is 2–4 MBq/kg body weight up to a maximum dose of 360 MBq.

SWAN-PSMA-1007 is administered by appropriately qualified professional medical staff.

^[4] _{MBq: A mega-Becquerel is the unit of activity of a determined quantity of a radioactive substance. M stands for “mega”, i.e. one million}

Efficacy

The efficacy of SWAN-PSMA-1007 was investigated in a randomised study^[5] entitled ABX-CT-301. This study compared SWAN-PSMA-1007 with [¹⁸F]-fluorocholine in patients whose prostate cancer had recurred after first treatment. The key data on efficacy were obtained in 190 participants who had each undergone PET-CT with both study medications. The primary goal of the study was to demonstrate the superiority of SWAN-PSMA-1007 over [¹⁸F]-fluorocholine as expressed in tumour detection rate. The PET-CT images were evaluated by independent assessors. The study showed that tumours were detected in 77% of cases with SWAN-PSMA-1007 compared with 57% of cases with [¹⁸F]-fluorocholine.

^[5] _{Randomised study: Tests different treatments by assigning participants to different groups at random.}

Precautions, undesirable effects & risks

SWAN-PSMA-1007 must not be used in those who are hypersensitive to the active substance or any of the excipients.

SWAN-PSMA-1007 should only be used by qualified specialists. It contributes to patients’ total long-term cumulative radiation exposure. This is associated with an increased risk of cancer.

No undesirable effects that are associated with SWAN-PSMA-1007 in clinical use have been reported to date.

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

Why the medicinal product has been authorised

Various imaging techniques are used to diagnose prostate cancer. The diagnostic radiopharmaceutical SWAN-PSMA-1007 offers a new option for the targeted identification of tumours. Clinical studies have shown that a better detection rate can be achieved with SWAN-PSMA-1007 than with [¹⁸F]-fluorocholine, the product that is currently authorised. The risks associated with the radioactive marker primarily involve increased radiation exposure. However, these can be minimised by appropriate handling.

Taking all the risks and precautions into account, and based on the available data, the benefits of SWAN-PSMA-1007 outweigh the risks. Swissmedic has therefore authorised the medicinal product SWAN-PSMA-1007, containing the active substance [¹⁸F]PSMA-1007, for use in Switzerland.

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.}