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FDA grants priority review qualification for ovarian cancer drug candidate Rucaparib

2016-08-26
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The FDA recently granted Clovis Oncology a priority review. The company is seeking approval for its experimental drug Rucaparib for the treatment of ovarian cancer. Once the news was released, the company’s stock price soared as much as 38%.

This PARP inhibitor is being evaluated for advanced ovarian cancer in patients with BRCA mutations (including germline and somatic BRCA mutations) who have previously been treated with at least two chemotherapy methods. Chief Executive Mahaffy said that the FDA’s decision was an important milestone for Rucaparib and Clovis.

The submission of application materials for the listing of this drug under Clovis is based on the effectiveness data of two studies in which 106 patients participated. The overall objective response rate of the two studies was 54%, of which the complete response rate and partial response rate were 9% and 45%, respectively. In addition, the median response time of the two studies was 9.2 months.

At the same time, safety evaluations were conducted in two studies of 377 patients who used Rucaparib twice a day. Clovis pointed out that adverse events that occurred in at least 10% of patients included anemia, fatigue, and elevated levels of aspartate transferase (AST) and alanine aminotransferase (ALT). The company also pointed out that AST and ALT levels were elevated Asymptomatic, it can be reversed.

Last year, Rucaparib was granted breakthrough therapy qualification by the FDA for the treatment of advanced ovarian cancer in patients who have been treated with at least two lines of platinum-containing drugs.

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