Rucaparib

Rucaparib (brand name Rubraca /ruːˈbrɑːkə/ roo-BRAH-kə) is a PARP inhibitor used as an anti-cancer agent. Rucaparib is a first-in-class pharmaceutical drug targeting the DNA repair enzyme poly-ADP ribose polymerase-1 (PARP-1). It was discovered as part of a collaboration between scientists working at the Northern Institute of Cancer Research and Medical School of Newcastle University and Agouron Pharmaceuticals in San Diego, California. It is being developed by Clovis Oncology. Rucaparib (brand name Rubraca /ruːˈbrɑːkə/ roo-BRAH-kə) is a PARP inhibitor used as an anti-cancer agent. Rucaparib is a first-in-class pharmaceutical drug targeting the DNA repair enzyme poly-ADP ribose polymerase-1 (PARP-1). It was discovered as part of a collaboration between scientists working at the Northern Institute of Cancer Research and Medical School of Newcastle University and Agouron Pharmaceuticals in San Diego, California. It is being developed by Clovis Oncology. In December 2016, the U.S. FDA granted an accelerated approval for use in cases of pretreated advanced ovarian cancer. In Europe it was designated as an orphan medicinal product on 10 October 2012. On 22 March 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation, intended for the treatment of relapsed or progressive ovarian cancer. It can be taken orally in tablet form. Rucaparib inhibits 'the contraction of isolated vascular smooth muscle, including that from the tumours of cancer patients. It also reduces the migration of some cancer and normal cells in culture.' As a PARP inhibitor, rucaparib is expected to be more effective in the 9% of pancreatic cancers with a BRCA mutation (BRCA1 or BRCA2). In 2013, a total of 106 patients from six different countries were enrolled into phase II trial (ARIEL2) to evaluate the activity of the investigational drug in women with platinum-sensitive advanced ovarian, fallopian tube, or primary peritoneal cancer. By 2015, the initial data from ARIEL2 were presented at ASCO, representing breakthrough therapy designation. of 106 patients in the study, 52 of the subjects did not show any adverse event, such as death or disease progression.Of these 52 patients, 18 subjects discontinued treatment for personal reasons. In the first quarter of 2016, the marketing applications were submitted in order to prove of the treatment of advanced ovarian cancer in women with deleterious BRCA mutation–positive (BRCAmut+). In June 2016, an NDA was filed with the FDA and the PDUFA date assigned for February 2017. However, surprisingly, rucaparib was granted fast-track status and was approved by the FDA in December 2016 as monotherapy treatment of mentioned patients who have been treated ≥2 prior chemotherapies. Furthermore, the FDA also approved the FoundationFocus CDxBRCA Test as the first next-generation sequencing (NGS)-based companion diagnostic to identify the most potent ovarian cancer patients who responded to rucaparib therapy. After the FDA approval, TRITON2 and TRITON3 mCRPC studies were initiated in order to determine how patients with prostate cancer will respond to the rucaparib drug. The studies for these two trials are still going on and the estimated dates for the first results are raging between 2019 through 2022.