FDA grants priority review to rucaparib for advanced BRCA –mutated ovarian cancer (see notes) Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Wednesday, August 24, 2016

FDA grants priority review to rucaparib for advanced BRCA –mutated ovarian cancer (see notes)



medical news:
FDA grants priority review to rucaparib for advanced BRCA –mutated ovarian cancer

 The ARIEL clinical development program evaluated rucaparib in women with advanced ovarian cancer.

Noteworth
  Aug 23 2016
 

FDA to review Clovis' rucaparib NDA for ovarian cancer, action date in six months; shares jump 31%


Battered and bruised Clovis Oncology (CLVS +31%) recaptures some its former glory on the news that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations and who have been treated with least two chemo regimens.
The NDA has Priority Review status which shortens the review clock to six months from the usual 10 months. The agency's action date (PDUFA) is February 23, 2017.
In two late-stage studies, the overall objective response rate for rucaparib-treated ovarian cancer patients was 54% (n=57/106).
Rucaparib is a small molecule poly ADP-ribose polymerase (PARP) inhibitor that specifically binds to PARP-1 and PARP-2. PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
Clovis had lost ~90% of its value since late 2015 when it stumbled with rociletinib. Shares have rebounded of late.  They are up more than 113% since bottoming at $11.57 on June 27.
PARP inhibitor competitor TESARO (TSRO -5.9%) slumps on the news.

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