The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for piflufolastat (18F) (Pylclari) to be used as a diagnostic tool in adults with suspected or confirmed prostate cancer.
The decision comes after a review of evidence from three key clinical trials, namely OSPREY, CONDOR, and PYTHON, which assessed piflufolastat (18F) for identifying prostate cancer cells using positron emission tomography (PET) scans.
In the OSPREY study, 385 men with prostate cancer received the medicine and underwent a PET scan to verify the location of cancer cells.
Results from the PET scan correctly showed the absence of cancer cells in parts of their prostate in more than 96% of patients, among the 252 subjects who got their prostate removed. Despite these promising results, statistical significance was not achieved.
The CONDOR trial enrolled 208 patients with suspected recurrent prostate cancer. Within 60 days before undergoing piflufolastat (18F) PET scans, all participants had negative or inconclusive results from conventional imaging evaluations.
The scan outcomes revealed the presence of at least one cancerous lesion in 59-66% of patients. Furthermore, the precise location of the lesion was accurately identified in 85%-87% of patients.
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PYTHON, a study with 215 male participants, showed that piflufolastat (18F) could reveal prostate cancer during PET scans compared to 18F-fluorocholine, another diagnostic agent, with detection rates of 58% versus 40%, respectively.
MHRA Healthcare Quality and Access interim executive director Julian Beach said: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
“We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.”
Administered as a single intravenous injection, piflufolastat (18F) targets the prostate-specific membrane antigen (PSMA), which is prevalent in prostate cancer cells.
Furthermore, MHRA has approved the use of the Rubidium (Rb82) Generator (RUBY-FILL) for cardiac imaging to assess blood flow and diagnose coronary heart disease (CHD).
It is administered through one or two injections, spaced at least ten minutes apart, with subsequent scans conducted within five minutes of each injection.
The radiopharmaceutical used in this diagnostic procedure contains a minimal amount of radioactivity, which accumulates temporarily in specific body regions.
Special cameras detect this radioactivity, allowing healthcare professionals to capture images that provide critical insights into the heart’s blood flow.
