The FDA sets October 16, 2014 as the target review date for Navidea Pharmaceuticals (NAVB) supplemental New Drug Application ((sNDA)) for the label expansion of Lymphoseek.
The expanded labeling will cover broader, more flexible uses in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities. This is the second sNDA for the product.
Lymphoseek's first sNDA pertains to its use as a sentinel lymph node detection agent in patients with head and neck cancer. The FDA granted it Fast Track designation and set a PDUFA date of June 16, 2014.
It is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
Mutual fund ownership has increased from 82 to 94 over the past 4 quarters.
Navidea Biopharma (NAVB +4.2%) says the FDA granted a priority review for an expanded use of its Lymphoseek drug for sentinel lymph node detection in patients with head and neck cancer.
The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options; Lymphoseek is already approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
Navidea Biopharmaceuticals (NAVB) announces a distribution agreement with Global Medical Solutions Taiwan for Lymphoseek.
NAVB says the deal builds "on the growth of Lymphoseek sales in the United States, which continue the positive trends recently reported."
The company says it will work with its partner to address Taiwanese regulatory requirements and expects "local approval in 2014-15," although Lymphoseek may be available prior to approval "in appropriate situations." (PR)
In other company news, NAVB says it will collaborate with the University of San Francisco "on a clinical study to evaluate, for the first time, the use and performance of technetiumlabeled tilmanocept in patients with Kaposi Sarcoma." (PR)