Health and Healthcare

Clovis Wins Big With FDA Update

Chris Lange

Published: October 2, 2018 12:10 pm

Last Updated: January 11, 2020 5:00 pm

Clovis Oncology Inc. (NASDAQ: CLVS) shares jumped on Tuesday after the U.S. Food and Drug Administration (FDA) gave a critical update.

The FDA granted Breakthrough Therapy designation for Rubraca (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor-directed therapy and taxane-based chemotherapy.

For some quick background: Breakthrough Therapy designation is intended to treat a serious or life-threatening disease or condition and whose preliminary clinical evidence may demonstrate substantial improvement on at least one clinically significant endpoint over available therapy.

The FDA previously granted Breakthrough Therapy designation to Rubraca for the monotherapy treatment of certain advanced ovarian cancer patients and then in December 2016 approved Rubraca.

Also the FDA approved Rubraca in a second indication, 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, in April 2018.

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

We are committed to the rapid development of Rubraca in mCRPC and we are obviously pleased to receive Breakthrough Therapy designation. We look forward to presenting the data that served as the basis of our BTD application at the ESMO conference later this month. We hope the decision by the FDA to grant this Breakthrough Therapy designation for Rubraca offers encouragement to the prostate cancer community, and we will do our best to make Rubraca available to eligible prostate cancer patients as quickly as possible.

Shares of Clovis were last seen up 11% at $32.50, with a consensus analyst price target of $65.67 and a 52-week trading range of $28.70 to $86.26.