Le Lézard
Classified in: Health, Business
Subject: FDA

Cardinal Healthtm Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK® Pediatric Indication


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 Healthtm 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 Healthtm 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:

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.

SOURCE Cardinal Health


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