FDA Breakthrough Therapy: Clovis Oncology’s Rucaparib For Ovarian Cancer
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.
• Study in women with gBRCA mutations
• ARIEL2 study.
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
|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|
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