New CAR-T therapies in South Korea to face stringent regulatory oversight

South Korea medicines regulator has issued guidelines to monitor the side effects of the two approved CAR-T therapies – Novartis’ (NOVN: VX) Kymriah (tisagenlecleucel) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’ Carvykti (ciltacabtagene autoleucel).

This will ensure a comprehensive database of adverse events including malignancies, if any in the local population, thereby ensuring patient safety in the country. However, regulatory focus on malignancy data might extend clinical trial timelines and increase costs for pipeline therapies, says sector analytics firm GlobalData.

The Korean Ministry of Food and Drug Safety (MFDS) has recently mandated the reporting of any suspected adverse reactions, including T-cell malignancies, to the Korea Institute of Drug Safety and Risk Management.