Lantheus submits drug master file for imaging biomarker

By staff writers

January 12, 2021 -- Lantheus Holdings, parent company of Lantheus Medical Imaging, said that it has filed a drug master file with the U.S. Food and Drug Administration (FDA) for NM-01, a PD-L1 imaging biomarker for use in nuclear medicine.

NM-01, which was licensed by Lantheus from NanoMab Technology in 2019, is a radiopharmaceutical biomarker that uses a camelid single-domain antibody and a technetium-99 radioisotope and has demonstrated a high affinity for PD-L1 protein, according to the company. Lantheus said that NM-01 potentially enables detection of PD-1 expression in tumors and could be used to evaluate patients before, during, or after treatment with immuno-oncology agents in clinical trials.

The company said it will also begin providing NM-01 to academic centers and pharmaceutical companies for use in immuno-oncology clinical trials this year.

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