Register Now
Why register?
 The leading web portal for pharmacy resources, news, education and careers November 21, 2017
Pharmacy Choice - Pharmaceutical News - Clovis Vaults as Study Data Published - November 21, 2017

Pharmacy News Article

 9/13/17 - Clovis Vaults as Study Data Published
Clovis Oncology Inc (NASDAQ: CLVS) shares rose after on word the company’s rucaparib ARIEL3 study met primary and secondary endpoints, and published today in The Lancet.

ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.

CEO Patrick Mahaffy exulted, “The publication of the ARIEL3 data in this prestigious, peer-review journal reinforces the importance of identifying new therapies that provide meaningful clinical benefit to women with advanced ovarian cancer, and speaks to the high quality of the study design and the data we were able to deliver.

“We extend our sincere thanks to the study investigators and authors, as well as the many patients, who supported and participated in ARIEL3.”

Based on the ARIEL3 findings, Clovis Oncology plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a second line or later maintenance treatment indication in ovarian cancer by the end of next month.

Then, early next year, early 2018, CLVS plans to file a Marketing Authorization Application in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2016, rucaparib became the first PARP inhibitor approved by the FDA as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer.

Clovis shares gained 55 cents to $71.16, early Wednesday afternoon.

Copyright © 2017 Media Corp. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry


Last Chance
Nov 21: Standards of Practice for Filling Controlled Substance Prescriptions in Florida
Last Chance
Nov 22: Medical Marijuana: Examining the Science, Not the Politics
Nov 27: Drug Diversion and the Law: Updates and Considerations
Nov 28: An Integrative Approach to Managing Arthritis
Nov 29: Influenza 2017-2018: An Update on Prevention and Treatment
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.

Websites »
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement