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US-based Navidea Biopharmaceuticals has announced the regulatory approval of Lymphoaim by the Central Drugs Standard Control Organisation (CDSCO).
Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.
External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumour, which have the highest probability of harbouring cancer.
Bengaluru-based Sayre Therapeutics will lead Lymphoaim commercialisation efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specialises in innovative treatment and medical device commercialisation in South Asia.
