Indian oncologists are convinced that the recent US Food and Drug Administration (FDA) approval of the radioactive diagnostic imaging agent ‘Lymphoseek’ would give an impetus to accurate cancer detection in the country.
Lymphoseek is the first new drug used for lymph node mapping which was approved in the last 30 years. It is is marketed by the Ohio, Dublin-based Navidea Biopharmaceuticals, Inc. and is launched specifically as an imaging drug to pinpoint lymph nodes. Other US FDA-approved drugs used for lymph node mapping included sulfur colloid in 1974 and isosulfan blue in 1981.
The cancer experts from Apollo Hospitals, Karnataka’s government cancer care centre, Kidwai Institute of Oncology and oncology care chain, Healthcare Global Enterprises, stated that the Lymphoseek is seen a big fillip in lymph nodes detection.
The technetium Tc 99m tilmanocept Injection, would facilitate oncologists locate lymph nodes common in breast cancer and melanoma or skin cancer patients. The accurate diagnosis would be a big benefit for cancer experts engaged in removing tumour-draining lymph nodes via surgical intervention.
The incidence of breast cancer globally is estimated at around 1.4 million new cases diagnosed annually and is now seen as the second highest after prostate cancer. In India, the prevalence is reported to be one in 22 women, according to the National Institute of Cancer at the National Institute of Health (NIH), USA.
The occurrence of melanoma skin cancers globally is 132,000 cases each year, according to the World Health Organisation (WHO).
Lymph nodes filter lymphatic fluid flows from the body’s tissues. The fluid may contain cancer cells, especially if the fluid drains in the region where the tumour is located. By surgically removing and examining the lymph nodes, doctors can sometimes determine if a cancer has spread, stated US FDA in its drug approval note.
“Removal and pathological examination of lymph nodes is an important diagnostic evaluation for some patients with breast cancer or melanoma. “To use Lymphoseek, doctors inject the drug into the tumour area and later, with a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity,” said Dr Shaw Chen, deputy director, Office of Drug Evaluation IV, US FDA’s Centre for Drug Evaluation and Research (CDER).
The radioactive diagnostic imaging agent Lymphoseek’s safety and effectiveness have been ascertained in two clinical trials involving 332 patients with melanoma and breast cancer. All patients were injected with Lymphoseek and blue dye which is another drug used to help locate lymph nodes.
Surgeons then removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye of Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek. The most common side effects identified in clinical trials was pain or irritation at the injection site, said US FDA report.
The oncologists in the country see it as a major breakthrough bringing the much needed early detection in breast and skin cancer.