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March 6, 2013

New Drug Approvals

rucaparib

Clovis Oncology, Inc.

ClinicalTrials.gov identifier: NCT01482715

http://clinicaltrials.gov/show/NCT01482715

Rucaparib (CO-338; formerly known as PF 01367338 and AG 14699) is a small molecule inhibitor of poly-adenosine disphosphate (ADP) ribose polymerase(PARP) being developed for antitumor therapy as monotherapy and in combination with a variety of chemotherapeutic agents as a chemosensitizer. The safety and efficacy of IV rucaparib administered in combination with chemotherapy has been evaluated in several Phase I and Phase II studies.

An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations, and in combination with carboplatin in patients with advanced solid tumors. For this study, it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of breast and ovarian cancer patients with evidence of a germline mutation, thereby limiting tumor progression and providing therapeutic benefit.

poly(ADP ribose) polymerase inhibition…

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