cheapest acronis true image home 2009 buy pdf converter buying excel 2007 cost of windows server 2008 r2 standard buying screenflow for mac buy autoroute 2011 cheap final cut express 4 cheap autocad 2009 download buy omnipage 17 best price office 2008 mac buy windows xp home edition upgrade buy acrobat 8 price of adobe creative suite 5 design premium buy mathworks matlab buy apple iwork 08 price of office 2010 professional plus cost of win xp home edition buy mac os x server 1.0 cheap photoshop cs3 uk buy windows 7 family pack in canada buy apple motion 4 buy windows 7 discount buy microsoft powerpoint 2008 cheap autodesk 3ds max cheap software microsoft office 2013 buy outlook download microsoft office discount for teachers cheap microsoft office 2010 students cheap adobe dreamweaver cs4 price of windows 7

Lymphoseek designated fast track status in head and neck cancer

Wed, Dec 11, 2013

Oral Cancer News

Author: press release

Navidea announced that the FDA has granted Fast Track designation to Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

Lymposeek Injection was evaluated in a prospective, open-label, multicenter, within-patient study (NEO3-06). It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection. A minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease was required. Thirty nine subjects out of over 80 subjects enrolled were determined to have pathology-positive lymph nodes.

Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before the end of 2013. Lymphoseek is already approved for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

Print Friendly
Be Sociable, Share!
, , ,

Leave a Reply

You must be logged in to post a comment.