FDA & PARGi

IDEAYA Receives Fast Track Designation for Potential First-in-Class PARG Inhibitor, IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients having tumours with BRCA1/2 Mutations

https://tinyurl.com/bdhy2uuj

Defective DNA repair is important as a cause for ovarian cancer and the prevention of cancer elimination once established. Personalised treatment using PARP inhibitors acts by blocking alternative repair pathways through a process called synthetic lethality. 

Unfortunately resistance to PARPi is inevitable. Often this occurs because another repair process becomes active. One such process is Poly (ADP-ribose) Glycohydralase (PARG). A new Drug IDE161 has been developed to inhibit this repair process in a similar manner to PARPi.

The FDA has given Fast Track approval for this drug as a preliminary to full access. Usually this implies the FDA has confidence that the new treatment for those women with ovarian cancer, who have become resistant, will have a good outcome. With time it may be that the role of PARGi expands to become an alternative to PARPi as maintenance therapy.