Clovis Oncology, headquartered in Boulder, CO received Breakthrough Designation from the FDA for its oncology drug rucaparib.  This BDT is indicated for advanced ovarian cancer patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations. Rucaparib is an oral inhibitor of PARP1 and PARP2 being developed by Clovis for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as “BRCA-like” or “BRCAness.” The BTD was based on promising results from two ongoing Phase II studies of rucaparib in ovarian cancer. In addition, the clinical data also demonstrate that Clovis’ proprietary BRCA-like DNA signature, a companion diagnostic test run by its partner Foundation Medicine, successfully predicts which ovarian cancer patients respond to rucaparib therapy.  Rucaparib is the first PARP inhibitor that received a BTD and Clovis is planning to file a NDA in 2016.

 

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