Lantheus Announces Presentations Featuring PYLARIFY (Piflufolastat F 18) Data at the ASCO GU Meeting
Lantheus Holdings (NASDAQ: LNTH) has announced upcoming presentations of piflufolastat F 18 (PYLARIFY) data at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco. Two key presentations will showcase PYLARIFY's capabilities: one focusing on early detection of recurrent prostate cancer in patients with minimal PSA levels, and another examining PYLARIFY's role in newly-diagnosed and recurrent prostate cancer patients based on registry data.
The presentations are scheduled for February 13, 2025, during Poster Session A, with studies from the University of California's Department of Radiation Oncology and Carolina Urologic Research Center. The research highlights PYLARIFY's effectiveness in real-world applications and its ability to detect prostate cancer recurrence in low PSA cases.
Lantheus Holdings (NASDAQ: LNTH) ha annunciato prossime presentazioni dei dati su piflufolastat F 18 (PYLARIFY) al Simposio sui Tumori Genito-Urinali ASCO 2025 a San Francisco. Due presentazioni chiave metteranno in evidenza le capacità di PYLARIFY: una si concentrerà sulla diagnosi precoce del cancro alla prostata ricorrente in pazienti con livelli minimi di PSA, e l'altra esaminerà il ruolo di PYLARIFY nei pazienti con cancro alla prostata neodiagnosticato e ricorrente basato su dati registrati.
Le presentazioni sono programmate per il 13 febbraio 2025, durante la Sessione Poster A, con studi provenienti dal Dipartimento di Oncologia Radioterapica dell'Università della California e dal Carolina Urologic Research Center. La ricerca mette in evidenza l'efficacia di PYLARIFY nelle applicazioni reali e la sua capacità di rilevare la ricorrenza del cancro alla prostata in casi con basso PSA.
Lantheus Holdings (NASDAQ: LNTH) ha anunciado presentaciones próximamente sobre los datos de piflufolastat F 18 (PYLARIFY) en el Simposio de Cáncer Genitourinario ASCO 2025 en San Francisco. Dos presentaciones clave mostrarán las capacidades de PYLARIFY: una se centrará en la detección temprana del cáncer de próstata recurrente en pacientes con niveles mínimos de PSA, y la otra examinará el papel de PYLARIFY en pacientes recién diagnosticados y recurrentes de cáncer de próstata basado en datos de registro.
Las presentaciones están programadas para el 13 de febrero de 2025, durante la Sesión de Póster A, con estudios del Departamento de Oncología Radioterápica de la Universidad de California y del Carolina Urologic Research Center. La investigación destaca la efectividad de PYLARIFY en aplicaciones del mundo real y su capacidad para detectar la recurrencia del cáncer de próstata en casos de bajo PSA.
Lantheus Holdings (NASDAQ: LNTH)가 샌프란시스코에서 열리는 2025 ASCO 비뇨기암 심포지엄에서 piflufolastat F 18 (PYLARIFY) 데이터 발표를 예정하고 있다고 발표했습니다. 두 가지 주요 발표가 PYLARIFY의 능력을 선보일 예정입니다: 하나는 PSA 수치가 최소인 환자에서 재발성 전립선암의 조기 발견에 초점을 맞추고, 다른 하나는 신규 진단 및 재발성 전립선암 환자에서 PYLARIFY의 역할을 등록 데이터에 기반하여 조사합니다.
발표는 2025년 2월 13일에 포스터 세션 A 동안 진행되며, 캘리포니아 대학교 방사선 종양학과와 캐롤라이나 비뇨기 연구 센터의 연구가 포함됩니다. 이 연구는 PYLARIFY의 실제 적용에서의 효과와 낮은 PSA 수치에서 전립선암 재발을 감지하는 능력을 강조합니다.
Lantheus Holdings (NASDAQ: LNTH) a annoncé la présentation prochaine de données sur le piflufolastat F 18 (PYLARIFY) lors du Symposium ASCO sur les Cancers Génito-urinaires 2025 à San Francisco. Deux présentations clés mettront en avant les capacités de PYLARIFY : l'une se concentrera sur la détection précoce du cancer de la prostate récidivant chez des patients avec des niveaux de PSA minimaux, et l'autre examinera le rôle de PYLARIFY chez les patients récemment diagnostiqués et récidivants, basé sur des données d'enregistrement.
Les présentations sont programmées pour le 13 février 2025, lors de la session de posters A, avec des études du département d'oncologie radiothérapeutique de l'université de Californie et du Carolina Urologic Research Center. La recherche met en lumière l'efficacité de PYLARIFY dans des applications réelles et sa capacité à détecter la récidive du cancer de la prostate dans les cas de PSA faible.
Lantheus Holdings (NASDAQ: LNTH) hat die bevorstehenden Präsentationen von Daten zu piflufolastat F 18 (PYLARIFY) beim 2025 ASCO Genitourinary Cancers Symposium in San Francisco angekündigt. Zwei wichtige Präsentationen werden die Fähigkeiten von PYLARIFY hervorheben: eine konzentriert sich auf die frühzeitige Erkennung von wiederkehrendem Prostatakrebs bei Patienten mit minimalen PSA-Werten, und die andere untersucht die Rolle von PYLARIFY bei neu diagnostizierten und wiederkehrenden Prostatakrebspatienten basierend auf Registrierungsdaten.
Die Präsentationen sind für den 13. Februar 2025 während der Poster-Session A geplant, mit Studien von der Abteilung für Strahlenonkologie der Universität von Kalifornien und dem Carolina Urologic Research Center. Die Forschung hebt die Wirksamkeit von PYLARIFY in der realen Anwendung hervor und zeigt dessen Fähigkeit, das Wiederauftreten von Prostatakrebs in Fällen mit niedrigem PSA zu erkennen.
- PYLARIFY demonstrates capability to detect prostate cancer recurrence in low PSA patients
- Real-world evidence from registry data supporting PYLARIFY's effectiveness
- None.
Data highlights PYLARIFY’s ability to detect recurrent prostate cancer in patients with low PSA
Real-world evidence of PYLARIFY’s effectiveness in prostate cancer being presented
BEDFORD, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced piflufolastat F 18 data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.
Presentation details are as follows:
Date & Time: Thursday, February 13, 2025, 11:25 am – 12:45 pm PT and 5:45 PM-6:45 PM PT
Session Number: Poster Session A
Session Title: Prostate Cancer
Title: Early Detection of Recurrent Prostate Cancer Using 18F-DCFPyL PET/CT in Patients with Minimal PSA Levels
Presenter: Ida Sonni, University of California, Department of Radiation Oncology
Poster Number: J8
Date & Time: Thursday, February 13, 2025, 11:25 am – 12:45 pm PT and 5:45 PM-6:45 PM PT
Session Number: Poster Session A
Session Title: Prostate Cancer
Title: The Role of Conventional Imaging and Piflufolastat F18 in Newly-Diagnosed and Recurrent Prostate Cancer Patients: Preliminary Observations from the PYLARIFY Registry
Presenter: Neal Shore, Carolina Urologic Research Center
Poster Number: A19
About PYLARIFY® (piflufolastat F 18) Injection
PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6
PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 400,000 scans across 48 states.
PYLARIFY® (piflufolastat F 18) Injection
Indication
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information
Contraindications
None.
Warnings and Precautions
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤
Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.
To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the accompanying full Prescribing Information also available at PYLARIFY.com.
About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.
Contacts:
Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com
FAQ
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