Lymphoseek recommended for approval in EU for certain cancers

Navidea Biopharmaceuticals announced Friday that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), is recommending marketing authorization in the European Union for Lymphoseek (tilmanocept) preparation for the presurgical mapping of sentinel lymph nodes that provide a point of potential metastasis in primary head and neck oral cavity squamous cell carcinoma, melanoma and breast cancer.

The Dublin, Ohio, based company will await further review by the European Commission and a decision on the matter is expected before the end of the year.

"This positive CHMP opinion moves Lymphoseek closer to becoming the first and only sentinel lymph node detection agent approved in all 28 member countries of European Union,” interim CEO of Navidea Michael Goldberg, MD, said in a press release. "We believe Lymphoseek is differentiated in its ability to reliably and accurately locate sentinel lymph nodes draining a tumor, to help more effectively stage cancer and inform post-surgical treatment, and to decrease patient morbidity.”

The value of sentinenal lymph node mapping is in the ability to save several benign lymph nodes without all of the potential adverse effects that go with invasive surgery. The recommendation is based on data from three phase three clinical trials involving select head and neck cancers, melanoma and breast cancer.

“The practice of Sentinel Lymph Node Biopsy (SLNB) may offer a less invasive and equally predictive alternative for patient staging and directing adequate treatment of the neck,” said Professor Remco de Bree, MD, PhD, from the department of head and neck surgery at the VU University Medical Center in Amsterdam, The Netherlands. “We welcome the addition of Lymphoseek in Europe as an approved sentinel lymph node detection agent with the potential to offer surgeons the ability to reliably and accurately guide SLNB procedures.”

Goldberg expects to be able to provide Lymphoseek to European clinicians sometime next year. Lymphoseek was first FDA approved in the U.S. for presurgical mapping of breast cancer and melanoma in March of last year.