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news.The US Food and Drug Administration (FDA) has granted priority review status to Clovis Oncology’s new drug application (NDA) for rucaparib as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least two or more prior lines of chemotherapy.
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The priority review status shortens the review clock to six months from the usual 10 months. The agency's action date (PDUFA) is 23 February 2017.
Clovis Oncology’s application is based on data from 106 patients across 2 trials, including the ARIEL2 study.
In a pooled analysis of data from the studies, the objective response rate was 54% with rucaparib.
Rucaparib earlier secured a breakthrough therapy designation from the FDA for the proposed indication in April 2015.
Clovis Oncology president and CEO Patrick Mahaffy said: “The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis.
“There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed to treat advanced ovarian cancer.
It is also being developed as maintenance therapy in the Ariel3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA.
Data from Ariel3 are expected in the fourth quarter of 2017, which is anticipated to be followed by the submission of a supplemental NDA for second-line maintenance therapy.
Clovis, which owns global rights for rucaparib, is also evaluating the drug in other solid tumor types with BRCA and HRD populations, including prostate, breast and gastroesophageal cancers.