U.S. regulators have granted a priority review to AstraZeneca’s ovarian cancer drug Lynparza as a treatment for breast cancer, putting the idea on track for potential approval inside the completely new disease area during the first quarter of 2018.
The medicine, which can be being jointly developed as well as marketed with Merck under a deal struck in July, can be the first poly ADP-ribose polymerase (PARP) drug to be considered for use outside ovarian cancer.
Lynparza can be also being tested in prostate as well as pancreatic cancers, the two companies said on Wednesday.
The successful breast cancer submission to the U.S. Food as well as Drug Administration follows a clinical study showing advanced breast cancer patients with certain gene mutations experienced double the response rate as well as delayed disease progression when treated with Lynparza compared with chemotherapy.
Lynparza – abandoned at one stage by AstraZeneca however revived by CEO Pascal Soriot when he took over in 2012 – became the first PARP drug to reach the market when the idea won U.S. approval for ovarian cancer at the end of 2014.
the idea right now faces competition through rival products made by Tesaro as well as Clovis Oncology that will are also approved for ovarian cancer.
PARP inhibitors work by blocking enzymes involved in repairing damaged DNA, thereby helping to kill cancer cells.