DUBLIN, Ohio, June 10, 2021 /PRNewswire/ -- Cardinal Health
(NYSE: CAH) today announced that LYMPHOSEEK® (technetium
Tc 99m tilmanocept) injection – the
first and only radiopharmaceutical agent specifically designed for
targeted lymphatic mapping and guiding sentinel lymph node biopsies
(SLNB) – has been approved for pediatric use by the U.S. Food and
Drug Administration (FDA).
"This new indication opens the door for physicians, oncologists
and nuclear medicine specialists to more accurately stage the
spread of disease using lymphatic mapping in pediatric cancer
patients," said Tiffany Olson,
President of Nuclear & Precision Health Solutions at Cardinal
Health. "Ultimately, this may help more families to be able to get
answers to some of their most concerning questions."
In addition to adult use, this new indication will provide
accurate and precise lymph node identification in pediatric
patients with melanoma, rhabdomyosarcoma (RMS) or other types of
solid tumors. This will offer physicians, oncologists and nuclear
medicine specialists an efficient, accurate and safe option to
enhance lymphatic mapping and SLNB in pediatric melanoma cases, the
most common skin cancer in children, which results in around 500
new cases per year [1].
Approximately the same number of pediatric cases of RMS, a rare
type of cancer that forms in soft tissues, such as eyes, occurs
each year in the United States.
RMS is most often diagnosed in children and teens, with more than
half of diagnoses in children younger than 10 years old
[2].
LYMPHOSEEK® is a radioactive diagnostic agent. A
clinical study to evaluate LYMPHOSEEK® in pediatric
patients has shown that the radiopharmaceutical is safe and
effective for patients one month and older. Less than one percent
of patients reported injection site irritation and/or pain in
clinical trials, with no serious adverse reactions to the drug
being reported.
With the largest national pharmacy network and the industry's
most comprehensive portfolio of radiopharmaceuticals – with
best-in-class service, accuracy and reliability to deliver
on-demand prescriptions across the country – Cardinal Health™
Nuclear & Precision Health Solutions is helping shape the
future of precision healthcare.
About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global
manufacturer and distributor of medical and laboratory products,
and a provider of performance and data solutions for health care
facilities. With 50 years in business, operations in more than
40 countries and approximately 48,000 employees globally,
Cardinal Health is essential to care. Information about Cardinal
Health is available at cardinalhealth.com.
About Nuclear & Precision Health Solutions:
Cardinal Health™ Nuclear & Precision Health Solutions develops,
manufactures, prepares, dispenses and delivers over 12 million
time-critical, patient-specific radiopharmaceutical doses annually
via a U.S. network of more than 130 nuclear pharmacies and more
than 30 PET sites and other manufacturing facilities.
Contacts
Media: Betsy Chaffee,
betsy.chaffee@cardinalhealth.com and 614.757.6219
Investors: Kevin
Moran, kevin.moran@cardinalhealth.com and 614.757.7942
References
[1] Strouse JJ,
Fears TR, Tucker MA, et al. Pediatric melanoma: risk factor and
survival analysis of the surveillance, Epidemiology and End Results
database. J Clin Oncol. 2005;
23:4735–41. [PubMed] [Google Scholar]
[2] American Cancer Society. Cancer Facts
& Figures 2020. Atlanta,
Ga: American Cancer Society; 2020.
Indications and Usage
LYMPHOSEEK® (technetium Tc 99m tilmanocept) injection is a radioactive
diagnostic agent indicated with or without scintigraphic imaging
for:
- Lymphatic mapping using a handheld gamma counter to locate
lymph nodes draining a primary tumor site in adult and pediatric
patients age one month and older with solid tumors for which this
procedure is a component of intraoperative management.
- Guiding sentinel lymph node biopsy using a handheld gamma
counter in patients with clinically node negative squamous cell
carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
Warnings and Precautions
LYMPHOSEEK® may pose a risk of hypersensitivity
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs). No serious
hypersensitivity reactions were reported in clinical trials with
LYMPHOSEEK®.
Before administering LYMPHOSEEK®, ask patients about
prior hypersensitivity reactions to drugs, especially to dextran
and modified forms of dextran. Have resuscitation equipment and
trained personnel immediately available at the time of
LYMPHOSEEK® administration.
LYMPHOSEEK® is a radioactive drug and should be
handled by or under the control of qualified and licensed
physicians with appropriate safety measures to help decrease
radiation exposure.
Any radiation-emitting product may increase the risk for cancer,
especially in pediatric patients. Adhere to the dose
recommendations and ensure safe handling to decrease the risk for
excessive radiation exposure to either patients or health care
workers.
Adverse Reactions
The most common adverse reactions are injection site irritation
and injection site pain (<1%).
There were no serious adverse reactions seen in clinical
trials.
Use in Specific Populations
No data are available on LYMPHOSEEK® use in pregnant
women. If considering LYMPHOSEEK® administration to a
pregnant woman, inform the patient about the potential for adverse
pregnancy outcomes based on the radiation dose from the drug and
the gestational timing of exposure.
No data are available regarding the presence of technetium Tc
99m tilmanocept in human milk, the
effects of the drug on the breastfed child, or the effects of the
drug on milk production. The benefits of breastfeeding should be
considered along with the mother's clinical need for
LYMPHOSEEK® and any potential adverse effects on the
breastfed child. If considering LYMPHOSEEK®
administration to a lactating woman, advise to pump and discard
breast milk for 24 hours after injection to decrease radiation
exposure to the breastfed child.
The safety and effectiveness of LYMPHOSEEK® have been
established in pediatric patients 1 month of age and
older.
In clinical studies, no differences in safety or efficacy have
been identified between elderly patients (65 to 90 years of age),
younger adult patients (18 to 65 years of age), and pediatric
patients (1 month of age and older).
Please see full Prescribing Information.
To report suspected adverse reactions, contact Cardinal Health
at 1.800.618.2768 or FDA at 1.800.FDA.1088 or
www.fda.gov/medwatch.
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SOURCE Cardinal Health