Associated Press
WASHINGTON — Women who have a cancerous lump removed from a breast won a new option Monday for the required follow-up treatment: a novel way to radiate just the tumor site instead of the whole breast.
Proxima Therapeutics Inc.’s MammoSite is designed specifically for breast brachytherapy — or targeted internal radiation — and was approved Monday by the Food and Drug Administration.
Brachytherapy proponents welcomed the move, noting that MammoSite-style radiation treatment takes just five days instead of up to seven weeks that external radiation can require.
MammoSite consists of a spaghetti-like hollow catheter with an inflatable balloon that is implanted at the tumor site when the tumor is removed. Later, a radioactive seed is inserted through the catheter, and a targeted dose of radiation emits through the balloon.
But some doctors worry about brachytherapy because it doesn’t hit cancer cells that may lurk in other parts of the breast, which external radiation could hit.
The FDA thus ordered Proxima to state that MammoSite isn’t a replacement for the whole-breast radiation that today’s cancer guidelines call for following a lumpectomy.
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