The new drug application (NDA) sent to the FDA includes a request to: priority rating, which, if granted, could shorten PyL’s regulatory review process from the usual 10 months to six. Lantheus expects the FDA’s decision on this application in early December.
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“The completion of our NDA filing marks an important milestone for Lantheus and our PyL clinical development program,” said Mary Anne Heino, president and CEO of Lantheus, in a statement. press release.
“Prostate cancer is the second leading cause of cancer death in men. Fortunately, men can live with their disease for a long time if they are treated appropriately,” Heino said. “We believe that, if approved, PyL will play a lasting role in the diagnosis and management of prostate cancer.”
PyL, also known as 18F-DCFPyl, is a tracking tool used in positron emission tomography or PET scans to visualize prostate cancer lesions in different types of tissues. It does this by targeting the prostate-specific membrane antigen (PSMA), a protein commonly found on the surface of prostate cancer cells. Once bound to these cells, PyL emits a radioactive signal that is visible in PET scans, indicating where these lesions are located.
The company’s NDA filing was supported by data from two clinical studies – OSPREY (NCT02981368) and CONDOR (NCT03739684) – which showed that PyL can detect local and distant prostate cancer lesions that conventional imaging methods sometimes lack. Such detection makes the tracking and spread of disease more accurate, allowing doctors to adjust treatment plans appropriately.
In the phase 2/3 OSPREY study, PyL showed good sensitivity and specificity in identifying cancer lesions in 385 men, divided into two groups. Group A included men with locally high risk advanced prostate cancer, while group B involved men with metastatic or recurrent disease. Note that in this context, sensitivity refers to the ability of PyL to identify true cancer sites, and specificity to its ability to distinguish cancer sites from non-cancerous (healthy) sites.
Among group A men, PyL had a specificity of 96-99%, a sensitivity of 31-42% and a positive predictive value (PPV) of 78-91% in identifying cancerous lesions in pelvic lymph nodes. The PPV is the proportion of patients with positive outcomes who actually have the disease.
In the group B participants, PyL had a sensitivity of 93-99% and a PPV of 81-88% in detecting metastatic cancer lesions, meaning those further away from the prostate. metastatic cancer is a disease that has spread to other parts of the body.
The participants tolerated PyL well and reported no serious unwanted side effects. The most common side effects observed were altered or unpleasant taste sensations and headache.
The Phase 3, open-label CONDOR study evaluated the ability of PyL to safely and accurately detect prostate cancer lesions in 208 men with suspected disease relapse. All patients enrolled in the study had high levels of prostate specific antigen (PSA), a prostate cancer biomarker, but had negative or equivocal imaging results.
The study achieved its main goal, with PyL correctly localizing cancer lesions in 85-87% of patients. As a result of these findings, nearly 64% of participants saw changes in their treatment plans.
“We are extremely grateful to the prostate cancer patients and researchers who participated in PyL’s clinical development program,” said Istvan Molnar, MD, chief medical officer of Lantheus.
“We believe that PyL’s demonstrated strong diagnostic performance will aid in treatment decisions and ultimately improve patient outcomes,” Molnar said. “We look forward to working with the FDA during the regulatory process in pursuing our goal of bringing PyL to patients.”
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