![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Niraparib Dramatically Increases Survival Time in BRCA-Mutated Ovarian Cancer
Niraparib Dramatically Increases Survival Time in BRCA-Mutated Ovarian Cancer
![](https://www.fdanews.com/ext/resources/test/Drug-Images3/colorpillsright.jpg?t=1433870462&width=430)
Niraparib almost quadrupled progression-free survival times in certain ovarian cancer patients compared to placebo, according to results from a Phase III trial.
In patients with germline BRCA mutations, niraparib, a PARP inhibitor developed by Tesaro, demonstrated a PFS of 21.0 months, compared to 5.5 months with placebo.
Niraparib also significantly improved PFS in patients with non-germline BRCA mutations, with a median of 9.3 months compared to 3.9 in the control group. In patients who were not germline BRCA mutation carriers, but whose tumors were determined to be HRD-positive, niraparib extended PFS to 12.9 months compared to 3.8 months with placebo.
Upcoming Events
-
21Oct