The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) from Lantheus Holdings for a new formulation of Pylarify, its prostate cancer PET imaging agent.
The novel formulation optimizes the manufacturing process and is expected to increase batch size by up to 50%, as well as increase the radioactive concentration of the agent, which could broaden patient access to prostate cancer imaging in new geographic locations, the company said.
The NDA was filed by affiliate Aphelion, and the FDA is expected to make a decision by March 6, 2026, Lantheus noted.
