| 2016-10-07 08:46:01|
CLVS 08:46 10/07 10/07/16
Clovis presents efficacy, safety data from NDA population for rucaparib at ESMO
Clovis Oncology announced the oral presentation of the primary efficacy and safety data from its NDA dataset for rucaparib at the 2016 ESMO Congress in Copenhagen. Rucaparib is currently under priority review with FDA for the monotherapy treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations who have been treated with two or more chemotherapies, and the submission has a PDUFA date of February 23, 2017. Rucaparib is the Company's oral, small molecule inhibitor of PARP1, PARP2 and PARP3 currently being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity also known as "BRCA-like." The current NDA submission seeks approval in patients with tumor BRCA mutations, which includes both germline and somatic mutations. These results demonstrate that rucaparib may represent an important option for women with multiply relapsed BRCA-mutated ovarian cancer based on its encouraging efficacy and tolerability," said Rebecca S. Kristeleit, MD, PhD, The University College London, Cancer Institute, London, UK. "In my opinion, rucaparib has the hallmarks of an important new therapeutic option for ovarian cancer patients." "We are pleased to present the primary efficacy and safety dataset that has been submitted to the FDA as the basis of our NDA for rucaparib in the treatment of advanced ovarian cancer. If approved, rucaparib would be the first PARP inhibitor in the U.S. indicated to treat ovarian cancer patients with germline or somatic BRCA mutations who have received two prior chemotherapies. Women with BRCA mutations represent about 25% of patients in the US living with ovarian cancer," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "Our NDA review is ongoing with FDA, and in addition we are actively preparing for a European submission during the fourth quarter of 2016."