Medicines Healthcare Products Regulatory Agency
Prostate cancer can develop when cells in the prostate start to grow in an uncontrolled way. Some prostate cancer grows very slowly meaning people can live for decades without symptoms or needing treatment. However, some prostate cancer grows quickly and requires treatment to stop it spreading.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
Were assured that the appropriate regulatory standards for the approval of this medicine have been met.
As with all products, we will keep its safety under close review.
Piflufolastat (18F) is administered under the supervision of a specialist doctor as a single injection into a vein of the arm. The injection is usually followed 90-120 minutes later by a Positron Emission Tomography (PET) scan, which is used in patients with prostate cancer to help the doctor locate the cancerous cells.
After being injected into a vein of the arm, piflufolastat (18F) binds to a specific protein called prostate-specific membrane antigen (PSMA) commonly found on prostate cancer cells. The small amount of radioactivity produced by piflufolastat (18F) helps the doctor to identify the locations of prostate cancer cells with a PET scan.
This regulatory approval is supported by evidence from three prospective, open-label, multi-centre clinical trials in men with prostate cancer: OSPREY (NCT02981368), CONDOR (NCT03739684), and PYTHON (EudraCT number 2020-000121-37).
In the OSPREY study of 385 men with prostate cancer, all patients received piflufolastat (18F) and underwent a PET scan to check the location of cancer cells. After three different doctors had looked at the scan, patients with high-risk cancer then had surgery to remove their prostate.
Among the 252 patients whose prostate was removed, the results of the PET scan correctly showed the absence of cancer cells in parts of their prostate in over 96% of patients. However, the results of the study were not statistically significant.
CONDOR enrolled 208 patients with biochemical evidence of suspected recurrent prostate cancer after initial treatment. All patients had negative or ambiguous conventional imaging evaluation results within 60 days of receiving piflufolastat (18F).
The results of the PET scan showed at least one cancer lesion in 59-66% of patients. The location of the lesion was correctly identified in 85-87% of patients.
PYTHON was a randomised, open-label, two-treatment cross-over study. It enrolled 215 male patients with suspected prostate cancer that had returned after treatment.
These patients received either piflufolastat (18F) or 18F-fluorocholine (another diagnostic medicine used for imaging) before they had a PET scan, and then received the other diagnostic medicine and had another PET scan up to 12 days later.
The PET scans revealed prostate cancer in 58% of these patients after they were given piflufolastat (18F), compared with 40% after patients had received the other diagnostic medicine.
Piflufolastat (18F) PET/CT had high concordance (agreement) of scan results with 18F-fluorcholine. However, the former was more sensitive for prostate cancer by around 18%.
The most common side effects of the medicine(which may affect more than 1 in 10 people) include dysgeusia (altered taste in the mouth) and headache.
As with any medicine, the MHRA will keep the safety and effectiveness of piflufolastat (18F) under close review. Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors?
- The new marketing authorisation was granted on 6 March 2024 to Curium Pharma UK Ltd.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- For more information about the clinical trials, see the Summary of Product Characteristics.
- For more information about prostate cancer, visit: https://prostatecanceruk.org
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal