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FDA Breakthrough Therapy: Clovis Oncology’s Rucaparib For Ovarian Cancer

April 7, 2015

Clovis Oncology, a Colorado-based biopharmaceutical company focusing on developing and delivering cancer drugs through personalized medicine, announces April 6th, that the FDA grants the Breakthrough Therapy Designation (BTD) to the company’s investigational agent Rucaparib. The BTD is for Rucaparib as a monotherapy treatment of advanced ovarian cancer in patients who have received at least 2 lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both gemline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations. Clovis Oncology plans on filing a FDA New Drug Application (NDA) for Rucaparib for treatment of advanced platinum-sensitive ovarian cancer in 2016.

Rucaparib, an oral potent inhibitor of PARP1 and PARP2, receives FDA Orphan Drug Designation (ODD) in July 2012 and EU ODD in October 2012. The BTD is granted based on 2 ongoing Phase II studies:

•   Study in women with gBRCA mutations

•   ARIEL2 study.

Per Clovis Oncology’s Press Release, for information about Rucaparib studies in ovarian cancer, visit the Ariel Study website.

This is the 2nd BTD Clovis Oncology has received. In May 2014, the FDA grants BTD to investigational agent CO-1686, as monotherapy for the treatment of second-line EGFR mutant Non-Small Cell Lung Cancer (NSCLC), in patients with the T790M mutation.

FDA ODD Database Record For Clovis Oncology

Generic Name: Rucaparib
Trade Name: n/a
Date Designated: 07-31-2012
Orphan Designation: Ovarian Cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Clovis Oncology, Inc. 2525 28th Street Suite 100 Boulder, CO 80301



Clovis Oncology Product Pipeline


FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “White Pocket Reflection” by John Fowler (Flickr: White Pocket Reflection) [CC BY 2.0] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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