Clovis Breaks Into Europe With EMA Validation

Health and Healthcare

Published: July 5, 2018 8:55 am

Last Updated: January 11, 2020 9:28 pm

Clovis Oncology Inc. (NASDAQ: CLVS) shares saw a bump early on Thursday after the company announced that the European Medicines Agency (EMA) has validated its application for a Type 2 variation to the marketing authorization for Rubraca (rucaparib). This validation confirms the submission is complete and begins the EMA’s centralized review process.

This application of Rubraca includes the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

This submission is based on the positive results from the Phase 3 ARIEL3 study, which evaluated rucaparib in the ovarian cancer maintenance treatment. Ultimately, ARIEL3 successfully achieved its primary endpoints, extending investigator assessed progression-free survival versus placebo in all patients treated.

Based on the timing of this submission, the company anticipates an opinion from the Committee for Medicinal Products for Human Use by end of 2018.

Patrick J. Mahaffy, CEO and president of Clovis, commented:

We are very pleased to receive validation of the variation to the Rubraca marketing authorization by the EMA, which brings us a step forward in making rucaparib available to more women with recurrent ovarian cancer in Europe.

Shares of Clovis closed Tuesday at $47.40, with a consensus analyst price target of $75.29 and a 52-week trading range of $41.31 to $99.45. Following the announcement, the stock was up about 1.3% at $48.00 in early trading indications Thursday.