The FDA has expanded the approval of Lymphoseek (technetium Tc 99m tilmanocept) injection to include lymphatic mapping in solid tumors and sentinel lymph node (SLN) detection for breast cancer and melanoma, according to Navidea Biopharmaceuticals, Inc. Additionally, the FDA has also approved the use of Lymphoseek with or without scintigraphic imaging for pre-operative mapping of lymph nodes, aimed to facilitate node localization during surgical procedures.
Regulatory
Bristol immunotherapy gets six month U.S. FDA review for melanoma
The U.S. Food and Drug Administration has granted a six-month, priority review to Bristol-Myers Squibb Co’s application for immuno-oncology drug Opdivo as a treatment for previously treated melanoma, the company said on Friday.
FDA Approves New Melanoma Drug that Turns On the Immune System to Fight Deadly Cancers
The U.S. Food and Drug Administration recently approved a new immunotherapy drug to treat advanced melanoma, signaling a paradigm shift in the way the deadly skin cancer is treated.
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.