NCI Cancer Bulletin for February 8, 2011 - National Cancer Institute: Another Radioactive Tracer Approved for Bone Scans

Another Radioactive Tracer Approved for Bone Scans

As a first step toward solving the ongoing shortage of a drug used in bone scans, called Technetium-99m (Tc-99m), NCI has won Food and Drug Administration (FDA) approval for a radioactive positron emission tomography (PET) tracer called Sodium Fluoride F18. This drug was originally approved in 1972 but was withdrawn in 1975, when a less-expensive alternative became available. This new approval covers a different dose and strength.

Radioactive tracers are used for bone scans with PET to diagnose skeletal metastases from primary cancers elsewhere in the body. Bone metastases are a serious issue for many types of cancer, particularly for patients with breast and prostate cancers.

One reason NCI submitted a New Drug Application (NDA) for Sodium Fluoride F18 was to make it possible for manufacturers to develop cheaper generic versions of the drug. The manufacturing of generic drugs could not begin until the NDA had been approved.

“We put together the NDA, and now that the drug has been approved, academic and commercial sites can file an abbreviated new drug application for generic versions,” said Dr. Paula M. Jacobs, acting associate director of NCI’s Division of Cancer Treatment and Diagnosis.

FDA approval is also important for reimbursement, noted Dr. Jacobs. The Centers for Medicare & Medicaid Services released a statement this week that it would reimburse for Sodium Fluoride F18 when patients are enrolled in a registry, and this could lead private insurers to do so, as well.

Until now, the only approved radioactive tracer has been Tc-99m. Over the last 5 years, there have been widespread shortages of that drug, which is a decay product of molybdenum-99 (Mo-99). The shortages, which are expected to continue for several more years, have been caused by problems with the few aging nuclear reactors that manufacture Mo-99, according to information from NCI’s Cancer Imaging Program.

A shortage of Mo-99 that lasts more than a week or two leads to immediate market shortages and can prevent clinicians from obtaining medical scans that use this agent. In 2007, more than 2.5 million patients underwent bone scans. Although not all of these scans used Tc-99m, millions of patients each year undergo scans involving radioactive tracers, noted Dr. Jacobs.

“The new approval will certainly help with the supply of these drugs going forward, and it will facilitate reimbursement,” she said.

See a history and rationale [http://imaging.cancer.gov/images/Documents/b9dbdfc1-9ce0-459d-a6b0-f4a1898cfd94/HisRatNaF.pdf] behind NCI’s filing of a New Drug Application for Sodium Fluoride F18.

NCI Cancer Bulletin for February 8, 2011 - National Cancer Institute