Technology | October 16, 2014

FDA Approves Expanded Use of Navidea’s Lymphoseek for Lymphatic Mapping in Solid Tumors

Radiopharmaceutical agent now approved for detection of breast cancer, melanoma

October 16, 2014 — Navidea Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications.  

Lymphoseek is now indicated for:

  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management; and
  • Guiding sentinel lymph node biopsy (SLNB) using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity, breast cancer or melanoma.

 

The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging, known as lymphoscintigraphy, to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection, is the only FDA-approved agent for lymphatic mapping of solid tumors and will be immediately available using existing reimbursement codes for this expanded population of cancer patients.

“Based on our clinical experience in melanoma and head and neck cancers, Lymphoseek appears to be an effective agent for cancer staging to guide pre- and intra-operative patient management and post-surgical treatment, thereby avoiding unnecessary surgical interventions, reducing surgical time and limiting potential complications with associated morbidity,” commented Stephen Y. Lai, M.D., Ph.D., FACS, associate professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. “The ability of Lymphoseek to accurately identify sentinel lymph nodes in patients, demonstrated in clinical evidence from more than 500 patients, may not only improve diagnostic accuracy but also enable more efficient and appropriate patient care and provide us with greater precision during surgery to detect lymph nodes with the highest likelihood of harboring tumor metastases.”  

“The success of lymphatic mapping and sentinel lymph node biopsy is dependent upon a radiopharmaceutical’s ability to concentrate in the lymph nodes most likely to contain cancer,” said H. William Strauss, M.D., attending physician emeritus, Molecular Imaging and Therapy Service at Memorial Sloan-Kettering Cancer Center. “Lymphoseek, with its specifically-designed ability to target molecular markers in tumor-draining lymph nodes, has shown through clinical studies in breast cancer, melanoma and certain head and neck cancers, to possess a high degree of sensitivity and accuracy. Based on the reliable performance of Lymphoseek as demonstrated in these tumor types, this approval opens up potential diagnostic imaging opportunities broadly across all forms of solid tumors.”

The expanded approval is supported by data from Navidea’s combined analysis of Lymphoseek’s pivotal prospective Phase 3 data in melanoma, breast cancer and certain head and neck cancers from more than 500 subjects. An integrated analysis of data from all three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied. The findings indicate that Lymphoseek accurately identified lymph nodes for assessment in the trial subjects, and is likely to be predictive of overall node pathology status. To date, no clinically significant drug-related adverse reactions have been reported. Lymphoseek has no contraindications and the most common adverse reactions were injection site irritation and/or pain (<1 percent).

In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.

For more information: www.lymphoseek.com

Related Content

News | Business | September 19, 2017
September 19, 2017 — Invicro LLC, a provider of imaging services and software for research and drug development, anno
ScImage and Invia Partnership Announced
News | PACS | September 19, 2017
ScImage Inc. and Invia Imaging Solutions recently announced formation of a joint partnership at the American Society of...
Theraclion to Launch Metastatic Breast Cancer Trial Combining Echotherapy and Immunotherapy
News | Focused Ultrasound Therapy | September 18, 2017
September 18, 2017 — Theraclion and co-lead investigator David Brenin, M.D., from the University of Virginia School o
Toshiba Highlights Latest CT Advancements at RSNA 2017
News | Computed Tomography (CT) | September 18, 2017
Toshiba Medical announced that it will display several new enhancements to its existing computed tomography (CT)...
Philips Launches CardioMD IV Cardiac SPECT Solution at ASNC 2017
Technology | SPECT Imaging | September 15, 2017
September 15, 2017 — Philips highlighted its newest solution for...
Double Targeting Ligands to Identify and Treat Prostate Cancer

The mice were imaged with small-animal PET/CT using 124I-RPS-027 (7.4 MBq [200 μCi]). Credit: JM Kelly et al., Department of Radiology, Weill Cornell Medicine, New York, NY

News | Prostate Cancer | September 14, 2017
Researchers have demonstrated a new, effective way to precisely identify and localize prostate cancer tumors while...
Blue Earth Diagnostics Announcing Results of FALCON PET/CT Trial at ASTRO 2017
News | PET-CT | September 13, 2017
September 13, 2017 — Blue Earth Diagnostics announced the upcoming oral presentation of initial results from the FALC
DenseBreast-info.org Debuts  Spanish Language Video  About Dense Breasts
News | Breast Density | September 12, 2017
Breast cancer risks associated with breast density are the subject of a new Spanish language video launched recently by...
Asian Study Underlines Potential Value of Pressure-Guided Mammography
News | Mammography | September 11, 2017
Sigmascreening recently announced that a study of in total 15,898 in digital mammograms from 3,772 Asian women...
Delphinus Enrolls First Patient in Discover Breast Ultrasound Clinical Project
News | Ultrasound Womens Healthcare | September 08, 2017
September 8, 2017 — Delphinus Medical Technologies Inc.
Overlay Init