New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 13, 2014
12:28 EDTNAVBNavidea confirms FDA approval of expanded use for Lymphoseek
Navidea Biopharmaceuticals announced that the FDA has approved the Supplemental New Drug Application for the expanded use of Lymphoseek Injection indicated for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. Lymphoseek becomes the first and only FDA-approved radiopharmaceutical application for sentinel lymph node detection and was first approved in March 2013 for lymphatic mapping in breast cancer and melanoma patients.
News For NAVB From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
March 25, 2015
07:32 EDTNAVBNavidea to present Lymphoseek injection data at SSO meeting
Navidea Biopharmaceuticals announced that data from its Lymphoseek injection studies in melanoma, breast and oral cavity squamous cell cancers will be presented at the 68th Annual Cancer Symposium of the Society of Surgical Oncology meeting held in Houston, TX, March 25-28. An oral presentation by Douglas Chepeha, M.D. of the University of Toronto-Princess Margaret Hospital reveals that analysis from Phase 3 data for detection of sentinel lymph nodes in head and neck oral cavity squamous cell carcinoma patients demonstrated high concordance between preoperative lymphoscintigraphy and intraoperative SLN biopsy findings. Notably, 95.2% of patients had agreement between their preoperative and intraoperative findings. This high concordance when using Lymphoseek confirms its role in the utility of preoperative lymphoscintigraphy imaging for planning and conducting SLN biopsy. Results of a follow-up outcome study presented as a poster by Julian Kim, M.D. of the University Hospitals Seidman Cancer Center indicated that in patients who were confirmed to be node-negative after sentinel lymph node biopsy the regional recurrence-free ratewas 98.8% at three years. An overall false negative rate for the two tumor types was 5.6% and the negative predictive value was 98.6%. These results demonstrate that Lymphoseek accurately identified SLNs and is likely predictive of pathological staging.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use