Pharmaceutical Executive November 3, 2023
Incidence rates have grown for leptomeningeal metastasis, a rapidly progressing and fatal complication of several cancers.
Plus Therapeutics has announced that the FDA granted orphan drug designation to rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases in breast cancer.1
The novel, injectable radiotherapy is designed to provide a highly targeted, high dose of radiation to metastases in the central nervous system (CNS). Rhenium-186 has a limited half-life, beta energy to destroy cancerous tissue, and gamma energy for live imaging, according to Plus Therapeutics.
“Receiving orphan drug designation from the FDA is important validation of our radiotherapeutic candidate for [patients with breast cancer] with leptomeningeal metastases who currently have no FDA-approved treatment options,” said Marc H. Hedrick, MD, president and...
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