Cytogen gets FDA approval for product licence application (PLA) supplement:
This article was originally published in Clinica
The US FDA has approved Cytogen's PLA supplement for its OncoScint CR/OV, expanding the imaging agent's indications to include readministration to HAMA-negative patients at risk of cancer recurrence. OncoScint received FDA approval in December 1992 and is the only such agent approved for tumour imaging, claims Cytogen. There have been around 150,000 cases of colorectal cancer each year in the US since 1990, according to the American Cancer Society.