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New Medicines

Locametz Prostate cancer imaging - identification of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adults

Information

Locametz
Radiopharmaceutical
Advanced Accelerator Applications (AAA)
Advanced Accelerator Applications (AAA)

Development and Regulatory status

Launched
Recommended for approval (Positive opinion)
Launched
September 2022
Oct 22 Recommended for EU approval by CHMP for use after radiolabelling with gallium 68 “for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: primary staging of patients with high risk PCa prior to primary curative therapy; suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy; or identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated.” Locametz will be available as a 25µg kit for radiopharmaceutical preparation [7].
Sep 22Available in UK. Pack size and price 25micrograms single vial - £1950 [6].
Aug 22MHRA approves Locametz 25micrograms kit for radiopharmaceutical preparation. The approved indication is "Locametz, after radiolabelling with gallium-68, is a radioactive diagnostic agent indicated for the identification of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adult patients with prostate cancer." [3].
Mar 22FDA approves Locametz (kit for preparation of 68Ga-gozetotide injection), a PET agent for PSMA-positive lesions, including selection of patients with metastatic prostate cancer for whom 177Lu-vipivotide tetraxetan PSMA-directed therapy (Pluvicto) is indicated. Locametz is the first radioactive diagnostic agent approved in the US for patient selection in the use of a radioligand therapeutic agent. Novartis, parent company of AAA, expects stock to be available in the US within weeks [4].

Category

Gallium (68Ga) gozetotide binds to cells that express PSMA, including malignant prostate cancer cells, which overexpress PSMA. Gallium-68 is a radionuclide with an emission yield that allows PET imaging. Based on the intensity of the signals, PET images obtained with gallium (68Ga) gozetotide indicate the presence of PSMA protein in tissues. Supplied as a kit for radiopharmaceutical preparation containing one vial of white lyophilised powder, for radiolabelling with gallium-68 chloride solution.
One in six UK males will be diagnosed with prostate cancer in their lifetime. In males in the UK, prostate cancer is the most common cancer, with around 52,300 new cases every year (2016-2018) [1]. PSMA is a cell surface transmembrane glycoprotein found in more than 90% of prostate cancer cells at levels 100–1000 greater than normal cells. 68Ga-PSMA-11 (Gallium) is the most widely studied and clinically incorporated radiotracer-PSMA ligand complex in PSMA imaging [2].
Prostate cancer imaging - identification of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adults
Intravenous

Trial or other data

Jan 21PIII VISION study (NCT03511664) completes collection of primary outcome data. The study (plus the VISION reviewer variability sub-study) was designed to establish the safety and efficacy of gallium (68Ga) gozetotide as a patient-identification method for PSMA-targeted therapy. Gallium (68Ga) gozetotide PET/CT imaging was used to identify 831 adult patients with metastatic prostate cancer and establish their eligibility for the study, based on the PSMA expression of their prostate cancer lesions. Patients were recruited in countries including, the US, UK, Netherlands, Germany, Canada, and more. Patients identified by gallium (68Ga) gozetotide PET/CT imaging had median OS of 15.3 months (95% CI: 14.2, 16.9) when receiving PSMA-targeted therapy (Pluvicto) plus BSoC and 11.3 months (95% CI: 9.8, 13.5) when receiving BSoC alone, with a hazard ratio of 0.62 (95% CI: 0.52, 0.74). The median rPFS was 8.7 months (99.2% CI: 7.9, 10.8) in patients receiving PSMA-targeted therapy (Pluvicto) plus BSoC, and 3.4 months (99.2% CI: 2.4, 4.0) in patients receiving BSoC alone, with a hazard ratio of 0.40 (99.2% CI: 0.29, 0.57). OS and rPFS outcomes support gallium (68Ga) gozetotide PET/CT imaging as a patient identification method for PSMA-targeted therapy in metastatic prostate cancer. A total of 1,003 adult male patients received gallium (68Ga) gozetotide at median dose per body weight of 1.9 MBq/kg (range: 0.9-3.7 MBq/kg) and underwent PET/CT image acquisition at approximately 60 minutes (range: 50-100 minutes) after injection. Gallium (68Ga) gozetotide PET/CT scans were assessed in conjunction with contrast-enhanced CT and/or MRI images and were read by independent central readers blinded to clinical information [3,5].