Posted On: 12/13/2013 1:30:59 AM
Post# of 47
That's great to hear that $NAVB Neoprobe Corporation received the go ahead to participate in the FDA's Fast Track Program for Lymphoseek.
I especially liked reading about these Phase 3 study results for "The first receptor-targeted radiopharmaceutical approved for lymphatic mapping in breast cancer and melanoma patients "
"The approval of Lymphoseek is based on data from more than 540 subjects receiving Lymphoseek. In pivotal Phase 3 studies that were conducted in 332 patients with either breast cancer or melanoma, Lymphoseek, on average, was present in 97% (range 94-100%) of resected, histology-confirmed lymph nodes. 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%)."
http://ir.navidea.com/phoenix.zhtml?c=68527&a...highlight=
I especially liked reading about these Phase 3 study results for "The first receptor-targeted radiopharmaceutical approved for lymphatic mapping in breast cancer and melanoma patients "
"The approval of Lymphoseek is based on data from more than 540 subjects receiving Lymphoseek. In pivotal Phase 3 studies that were conducted in 332 patients with either breast cancer or melanoma, Lymphoseek, on average, was present in 97% (range 94-100%) of resected, histology-confirmed lymph nodes. 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%)."
http://ir.navidea.com/phoenix.zhtml?c=68527&a...highlight=
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