Clovis’ submission of the therapy was backed by efficacy data from two studies involving a total of 106 patients. The overall objective response rate for the two studies was 54 percent, including complete response and partial response rates of 9 percent and 45 percent, respectively. Moreover, the median duration of response in the studies was 9.2 months.
Meanwhile, the safety assessment was performed in 377 patients administered rucaparib twice daily in the two studies. Clovis noted that adverse events that occurred in at least 10 percent of patients included anaemia, fatigue and increased aspartate transferase (AST) and alanine aminotransferase (ALT) levels, adding that the increases in AST and ALT levels were asymptomatic and reversibleClick here for reuse options!