FDA awards priority review to Clovis’ investigational ovarian cancer drug rucaparib, shares rise

  • The FDA on Tuesday granted priority review to Clovis Oncology’s filing seeking approval of the experimental ovarian cancer treatment rucaparib, sending shares in the drugmaker up as much as 38 percent.
  • The PARP inhibitor is being assessed for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumours, including both germline and somatic BRCA mutations, who were previously treated with at least two chemotherapies.
  • CEO Patrick Mahaffy described the decision as “an important milestone for rucaparib, and for Clovis.”

biotech news

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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.

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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 reversible

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Richard Dambrosi (JADTECNIC) Has Been Sharing FOREX INVESTORS ANALYSIS FORECAST since 2011. Editors and Founder of InvestorsBuz.com, has a passion for Forex Social Sharing analysis and Market Trends Such as Self Driving Cars, Electric Cars, Medical Marijuana, 3d printing and Cloud computing, Refers to Readers as BUZ INVESTORS.

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