Curium’s groundbreaking PYTHON trial has achieved a major breakthrough in the world of nuclear medicine. The European, multicenter, prospective cross-over study, which compared the efficiency of [18F] piflufolastat and [18F] fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer, recently achieved a major milestone.
Published ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023, the results of PYTHON have revolutionized the field, and promise to have a lasting impact on the treatment of prostate cancer and nuclear medicine as a whole.
The European Medicines Agency recommended on May 2023 that PYLCLARI® (piflufolastat (18F)) be granted a marketing authorization for its use in detecting prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET).
This decision was based on the Phase III PYTHON clinical trial conducted in Europe, and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S. With this decision, PYLCLARI® is now available to play an important role in the diagnosis and treatment of prostate cancer.
Adequate restaging of biochemically relapsed prostate cancer patients is essential to ensure they receive the maximum benefit from treatment. The PYTHON trial results demonstrate the superiority of [18F]DCFPyL PET/CT relative to [18F]fluoromethylcholine PET/CT, effectively paving the way towards personalized therapy.
According to lead author of the PYTHON Manuscript, Assoc. Professor in Nuclear Medicine, MD PhD, Dr. Daniela E. Oprea-Lager of Amsterdam UMC, this is an exciting advancement in prostate cancer care.
Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium, expressed his excitement over the success of their efforts at developing new diagnostic imaging solutions through a recently published manuscript on [18F]fluoromethylcholine – an established standard for PET/CT imaging of prostate cancer in Europe. Through this research, they are pushing the boundaries of the nuclear medicine experience and redefining our understanding of cancer.
In May 2021, the United States Food and Drug Administration (FDA) gave the green light to the revolutionary new anticancer drug PYLARIFY®, developed by Lantheus and based on the compound piflufolastat (18F). PYLARIFY® is now available and is a major breakthrough in the battle against cancer.
PYTHON Study
The PYTHON Study (NCT04734184) was a groundbreaking Phase III trial that provided a beacon of hope for those suffering from recurrent cancer. This European multicenter cross-over project compared the detection rates and impact on patient management of two radiopharmaceuticals – [18F]DCFPyL and [18F]fluoromethylcholine – for treating those suffering from cancer after initial definitive treatment with curative intent. Happily, the trial successfully met the primary endpoint, offering renewed hope for cancer patients across Europe.
About PYLARIFY® (piflufolastat F 18, also known as [18F]DCFPyL) Injection
PYLARIFY® (piflufolastat F 18) injection is an innovative PET imaging agent that can be used to detect recurrent and/or metastatic prostate cancer. It uses the combination of PET imaging, PSMA targeting and an F 18 radioisotope to create an incredibly precise and accurate image that allows healthcare professionals to diagnose prostate cancer with greater clarity.
The recommended dose for PYLARIFY is 333 MBq (9 mCi), with an acceptable dosage range of 296 MBq to 370 MBq (8 mCi to 10 mCi). With PYLARIFY, healthcare providers have access to a powerful tool that can help them make more informed decisions about the management of prostate cancer.
PYLARIFY, offering a safe and effective imaging solution, has been given the green light by the FDA and is now commercially available in the U.S. thanks to Lantheus. Moreover, in 2019 Curium acquired exclusive European rights to the product from Progenics, a Lantheus-affiliate.
About Curium
Curium is the global leader in revolutionizing nuclear medicine. Our pioneering approach and impressive legacy are setting the standard for excellence when it comes to providing superior radiopharmaceutical products and patient care.
Our commitment to innovation, excellence, and outstanding service is unmatched in the industry, making us the first choice for customers worldwide.