Radiopharmaceutical firm Cellectar Biosciences said the U.S. Food and Drug Administration (FDA) has determined that its CLR1502 tumor margin illumination agent will be evaluated as a combination product and assigned to the Center for Devices and Radiological Health (CDRH).
As a result, Cellectar will need to submit a new investigational new drug (IND) application for CLR1502 in combination with a light-source technology prior to beginning its planned proof-of-concept breast cancer surgery trial, according to the firm.
Cellectar President and CEO Dr. Simon Pedder said that CLR1502 shares similar spectral qualities with indocyanine green, a fluorescent dye commonly used in medical diagnostics. As a result, the agent can be used with several commercially available fluorescent imaging devices. These devices are currently limited to FDA-cleared applications such as cardiac, circulatory, hepatic, and ophthalmic conditions, he said in a statement.
The FDA told Cellectar that the combination product designation is not binding and can be revised later in the firm's development program. Furthermore, the company is not necessarily precluded from filing a standalone new drug application (NDA) in the future, Cellectar said.
