Clovis gets approval for Rubraca from European Commission

BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) has had its drug Rubraca, also known as rucaparib, authorized by the European Commission for use as a monotherapy treatment for adults with certain types of ovarian, fallopian tube or primary peritoneal cancers.

“Rucaparib provides a unique opportunity within Europe for women with BRCA mutated ovarian cancer, for whom platinum chemotherapy isn’t an option, to receive an oral non-chemotherapy treatment,” Dr. Rebecca Kristeleit, clinical senior lecturer and consultant medical oncologist at University College London in the U.K, said in a prepared statement. “In this group of patients with limited treatment options, rucaparib provides a much-needed oral targeted therapy for these women.”

The approval was based on data from two clinical trials. The project that led to the discovery of rucaparib was started at Newcastle University. Rucaparib went into Phase 1 trials back in 2003.

“We are pleased to receive this important authorization, as new options for women with recurrent ovarian cancer are needed,” Patrick J. Mahaffy, CEO and president of Clovis Oncology, said in a prepared statement. “Importantly, the granting of the license means we are now able to submit a variation to the Marketing Authorization for rucaparib to include the maintenance treatment setting based on ARIEL3 data, where we may soon be able to offer a new option to a larger population of women with recurrent ovarian cancer.”

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