As stated by the manufacturer of the agent, FDA has granted priority review to Rubraca for the treatment of advanced prostate cancer.
This alias is applied to the use of rucaparib, which is a poly (ADP-ribose) polymerase inhibitor used as monotherapy for males possessing BRCA1/BRCA2. BRCA1/BRCA2 is a metastatic castration-resistant, mutant regular prostate cancer.
This year, an approximated 43,000 men based in the U.S. are predicted to be diagnosed with metastatic castration-resistant prostate cancer. As stated by the American Cancer Society, in about 5 years time, nearly 30% of these men will continue to survive.
Deadly germline and/or somatic mutations in BRCA1 or BRCA2 will be harbored by approximately 12% of the men with metastatic castration-resistant prostate cancer. With the PARP inhibitors, these mutations can be used to lead patient selection for the treatment.
The president and chief executive officer of Clovis Oncology, Patrick J. Mahaffy stated in a press release how, according to recent data, Rubraca might play a significant role in the treatment of patients with [BRCA1/BRCA2]-mutant recurrent, metastatic [castration]-resistant prostate cancer. An important milestone is achieved for Clovis by this filing, as now we are one step closer to potentially making this valuable therapy available. He added that FDA’s decision to grant priority review to the Rubraca application has encouraged them considerably. He said that this will aid them in directing their attention to eligible patients possessing advanced prostate cancer, who require new treatment options urgently.
A decision on approval by the FDA is scheduled to be made on the 15th of May.
Multiple tumor types, including pancreatic cancer are said to be treated by the yet developing Rucaparib. For the treatment of women with fallopian tube, primary peritoneal cancer and epithelial ovarian, the United States has approved the agent.