- The submission follows the completion of the Phase 3 PYTHON clinical trial. [18F]- DCFPyL for recurrent prostate cancer in Europe in May 2022
- Results from the Phase 3 PYTHON clinical trial will be presented at the 35th Annual Congress of the European Society of Nuclear Medicine, October 15-19, 2022 in Barcelona, Spain.
PARIS, June 27, 2022 (GLOBE NEWSWIRE) — Curium, the world’s leading nuclear medicine company, today announced [18F]- DCFPyL to the European Medicines Agency. The application will be made two months after the completion of the Phase 3 PYTHON trial. [18F]-DCFPyL, following two US pivotal trials of OSPREY and CONDOR by Progenics Pharmaceuticals, Inc., a subsidiary of Lantheus. in the United States, [18F]-DCFPyL was approved by the FDA in May 2021 and is marketed as PYLARIFY.® (Piflufolastat F 18 Injection), commercially available from Lantheus.
Curium’s Chief Medical Officer, Sakir Mutevelic, MD, MSc, said:: “Positive results of the Phase III PYTHON clinical trial conducted in Europe [18F]- DCFPyL in the pivotal OSPREY and CONDOR clinical trials in multistage prostate cancer disease. [18F]-DCFPyL and its role in helping Curium redefine the cancer experience. ”
Benoit Woessmer, Curium’s Chief Executive Officer of PET Europe, added: “The completion of the PYTHON clinical trial and the submission of the Marketing Authorization Application to the European Medicines Agency demonstrate Curium’s continued dedication and commitment to developing life-saving diagnostic solutions for cancer patients worldwide. With Europe’s largest and most advanced PET radiopharmaceutical network, Curium is ready to make its products available across Europe after approval to have an everyday impact on patients and people. increase.”
The PYTHON study (NCT04734184) was a Phase III, European, multicenter, prospective crossover controlled trial to evaluate and compare detection rates, impact on patient management and safety profile. [18F]-DCFPyL and [18F]- Fluorocholine in patients with first biochemical recurrence (currently approved and established gold standard for PET/CT imaging of prostate cancer in Europe) (BCR) After initial curative treatment with curative intent. The trial met its primary endpoint.
Details and clinical results of the PYTHON study will be presented at the 35th Annual Congress of the European Society of Nuclear Medicine in Barcelona, Spain, October 15-19, 2022.
Pyralify® (piflufolastat F18) injection
in the United States, [18F]-DCFPyL was approved by the FDA in May 2021 and is marketed as PYLARIFY.® (Piflufolastat F 18 Injection), commercially available from Lantheus.
Pyralify® (Piflufolastat F 18) injection is a radiodiagnostic indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.
- Patients with suspected metastases who are candidates for first-line definitive therapy
- Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels
Important safety information
Warnings and cautions
Image misinterpretation risk
Image interpretation errors can occur in PYLARIFY imaging. A negative image does not deny the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Her PYLARIFY performance in imaging patients with biochemical evidence of prostate cancer recurrence appears to be affected by serum PSA levels. Prior to initial definitive therapy, her PYLARIFY performance for imaging metastatic pelvic lymph nodes appears to be influenced by risk factors such as Gleason score and tumor stage. Uptake of PYLARIFY is not specific to prostate cancer and may occur in other types of cancer, non-malignant processes and normal tissues. Clinical correlation, including histopathologic evaluation of suspected prostate cancer sites, is recommended.
Monitor the patient for hypersensitivity reactions. Particular caution should be exercised in patients with a history of allergies to other drugs or foods. Response may be delayed. Always have trained staff and resuscitation equipment available.
Diagnostic radiopharmaceuticals, including PYLARIFY, expose the patient to radiation. Radiation exposure is associated with a dose-dependent increase in cancer risk. Ensure safe handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure. Patients should be advised to drink fluids before and after dosing and to urinate frequently after dosing.
The most commonly reported side effects were headache, dysgeusia and fatigue, occurring at a rate of ≤2% during clinical trials of PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one of her patients (0.2%) with a history of allergic reactions.
Other therapies that target the androgen pathway, such as androgen deprivation therapy (ADT) and androgen receptor antagonists, may alter the uptake of PYLARIFY in prostate cancer. The effect of these treatments on PYLARIFY PET performance has not been established.
To report a suspected side effect of PYLARIFY, call 1-800-362-2668, contact FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.
See below for important risk and use information regarding PYLARIFY injections. Full prescribing information.
Curium is the world’s largest nuclear medicine company. We develop, manufacture and market world-class radiopharmaceutical products to help patients around the world. Our proven heritage combined with a pioneering approach are hallmarks for delivering innovation, excellence and unparalleled service.
With manufacturing facilities in Europe and the United States, Curium serves more than 14 million patients annually with SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases. The name “curium” honors the work of pioneering radiologists Marie-Her Curie and Pierre-Her Curie, after whom the radioactive element curium was named, giving us access to nuclear medicine. is emphasized. For more information, visit curiumpharma.com.
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