CLVS - Clovis files for US EU approval of Rubraca as initial maintenance therapy for ovarian cancer

Clovis Oncology ( NASDAQ: CLVS ) said it submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of Rubraca (rucaparib) as a first-line maintenance therapy for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy.

The filings of a supplemental New Drug Application (sNDA) to the FDA and a Type II variation to the EMA were backed by data from a phase 3 trial called ATHENA (ATHENA-MONO), the company said in a Sept. 13 press release.

Clovis noted that it had previously disclosed, that the FDA recommended to wait for more mature overall survival data from ATHENA-MONO before filing the sNDA but if the company chooses to submit the data before that then the application may need to be discussed at an Oncologic Drugs Advisory Committee meeting of the FDA.

"We believe the compelling PFS results, the primary endpoint of the ATHENA-MONO trial, are strongly supportive of an approval and reinforce the potential of Rubraca as an important new first-line maintenance treatment for ovarian cancer," said Clovis President and CEO Patrick Mahaffy.

CLVS -2.67% to $1.46 premarket Sept. 13

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