Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting
February 10 2022 - 5:33PM
Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an
established leader and fully integrated provider committed to
innovative imaging diagnostics, targeted therapeutics and
artificial intelligence solutions to find, fight and follow serious
medical conditions, announced today that data from the OSPREY
pivotal trial has been selected for presentation at the upcoming
2022 American Society for Clinical Oncology Genitourinary (ASCO GU)
Meeting, which will be held February 17-19, 2022 in San Francisco,
CA.
Presentation details are as follows:
Date & Time: February 17, 2022, 11:30 –
1:00 PM PT and 5:45 – 6:45 PM PTSession Title:
Poster Session A: Prostate CancerTitle:
Piflufolastat F 18-PET/CT in Prostate Cancer (PCa) Patients (Pts):
An Analysis of OSPREY (Cohorts A and B) Standardized Uptake Value
(SUV) Results Stratified by PSA and Gleason Score
(GS)Presenter: Michael Gorin, M.D., Urology
Associates & UPMC Western MarylandAbstract No:
35
About PYLARIFY® (piflufolastat F 18)
InjectionPYLARIFY® (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.4-9
PYLARIFY® (piflufolastat
F 18)
InjectionIndicationPYLARIFY® (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
InformationContraindicationsNone.Warnings
and PrecautionsRisk of Image MisinterpretationImaging
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
ReactionsMonitor 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 RisksDiagnostic
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 ReactionsThe most
frequently reported adverse reactions were headaches, dysgeusia and
fatigue, occurring at rate of ≤2% during clinical studies with
PYLARIFY. In addition, a delayed hypersensitivity reaction was
reported in one patient (0.2%) with a history of allergic
reactions.Drug interactionsAndrogen 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.For important risk
and use information about PYLARIFY Injection, please
see Full Prescribing information.
About Lantheus Holdings, Inc. Lantheus
Holdings, Inc. is the parent company of Lantheus Medical
Imaging, Inc., Progenics Pharmaceuticals,
Inc. and EXINI Diagnostics AB and an established
leader and fully integrated provider committed to innovative
imaging diagnostics, targeted therapeutics and artificial
intelligence solutions to Find Fight and Follow® serious
medical conditions. Lantheus provides a broad portfolio of
products, including the echocardiography agent DEFINITY® Vial
for (Perflutren Lipid Microsphere) Injectable Suspension;
PYLARIFY®, a PSMA PET imaging agent for the detection of suspected
recurrent or metastatic prostate cancer; PYLARIFY AI™, an
artificial intelligence platform that assists in the evaluation of
PSMA PET images; TechneLite® (Technetium Tc99m Generator), a
technetium-based generator that provides the essential medical
isotope used in nuclear medicine procedures; AZEDRA® for the
treatment of certain rare neuroendocrine tumors; and
RELISTOR® for the treatment of opioid-induced constipation,
which is partnered with Bausch Health Companies, Inc. The Company
is headquartered in North Billerica, Massachusetts with
offices in New Jersey, Canada and Sweden. For
more information, visit www.lantheus.com.
Contacts:Mark KinarneySenior Director, Investor
Relations978-671-8842ir@lantheus.com
Melissa Downs Director, Corporate
Communications646-975-2533media@lantheus.com
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