The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for trofolastat (RoTecPSMA), a prostate-specific membrane antigen (PSMA)-targeting agent for detecting cancerous lesions in men with prostate cancer.
Trofolastat, which was initially developed by Progenics Pharmaceuticals, is combined with Technetium-99m, a radioactive isotope widely used in diagnostic imaging, to form Technetium (99mTc) trofolastat.
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Administered as a single injection, Technetium (99mTc) trofolastat binds to PSMA proteins found on prostate cancer cells to aid doctors in identifying cancerous areas when undertaking the medical imaging technique single photon emission computed tomography (SPECT).
The agent is authorised in the clinical areas of identifying how far high-risk prostate cancer has spread before treatment, detecting recurrence in patients with rising prostate-specific antigen (PSA) levels, and determining whether targeted therapies may be effective for metastatic prostate cancer patients.
The MHRA stated that Technetium (99mTc) trofolastat’s approval was based on supporting evidence from a multi-centre, prospective study of 105 prostate cancer patients wherein the agent demonstrated a 94.2% sensitivity in identifying prostate cancer lesions.
Julian Beach, interim executive director for the MHRA’s healthcare quality and access division commented: “As the first PSMA-targeting diagnostic product approved with Technetium-99m, which is widely available in UK nuclear medicine facilities, this approval has the potential to expand access to prostate cancer imaging and support diagnostic pathways within the UK National Health Service (NHS).”
Diagnostic imaging is a critical process in identifying cancerous areas and informing treatment decisions for prostate cancer, which is the one of the most commonly diagnosed cancers in UK men, with around 55,000 new cases in the country each year, as per Cancer Research UK.
This week, the MHRA introduced new monthly safety bulletins aimed at making medical device and medicine safety information clearer and more accessible for healthcare professionals.
In other prostate cancer diagnostic news, last month Cambridge, UK-based EDX Medical shared details about its newly developed non-invasive prostate cancer test, which measures 100 clinically validated prostate cancer biomarkers, the most currently known, as per the company, in both blood and urine samples.
Various other companies have recently made strides in the field of prostate cancer diagnostics. Telix Pharmaceuticals’ Illucix prostate cancer imaging agent recently gained approval from the Brazilian Health Regulatory Agency (ANVISA), while Lynx Dx recent launched MyProstateScore 2.0, a urine test kit for prostate cancer intended for at-home sample collection by patients.
Olympic medallist Sir Chris Hoy, who was diagnosed with stage four prostate cancer in September 2023, has also been backing a UK campaign urging men to take 30 seconds for a simple online check.
