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EMA requests further review of Clovis' ovarian cancer treatment

Clovis Oncology Inc.'s market authorization application for Rucaparib will require further review before approval.

Rucaparib is being developed in ovarian cancer as well as several additional solid tumor indications.

The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has requested the Scientific Advisory Group on Oncology to provide an opinion on aspects of the ongoing marketing authorization application relating to a potential conditional approval for the drug.

The group is convened at the request of the EMA to provide independent recommendations on scientific or technical matters related to pediatric and adult clinical oncology and hematology, or on any other scientific issue.

Clovis said the exact date for the group's meeting has not yet been set but the company expects it to take place in early February 2018.

The company submitted the marketing authorization application in the fourth quarter of 2016.

In January 2018, the company plans to notify the EMA of its intent to submit a new application in the second quarter of 2018 for the maintenance treatment indication in women with advanced ovarian cancer.

If it gets a positive CHMP opinion and corresponding EMA approval, Clovis plans to file a variation to the application for the maintenance treatment indication based on that approval and would not proceed with the new application.

Earlier in December 2016, Clovis won approval from the U.S. Food and Drug Administration for the drug, known as Rubraca in the U.S.