Colorado-based biopharmaceutical company, Clovis Oncology (Nasdaq:CLVS) has received approval from the United States Food and Drug Administration (FDA) today for the company’s ovarian cancer maintenance treatment, RUBRACA (rucaparib).
RUBRACA, which is available in the form of tablets, is meant to be a maintenance treatment for women who have “recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer” and “are in a complete or partial response to platinum-based chemotherapy.”
According to professor and Executive Director of the Cancer Network Research and Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston, Robert L. Coleman, “Rubraca provided statistically-significant improvement in” progression-free survival (PFS) “versus placebo to all patients, regardless of BRCA mutation status.”
The FDA received the company’s supplemental New Drug Application (sNDA) for RUBRACA in December 2017. The approval was based on positive data results from Clovis Oncology’ phase 3 ARIEL3 clinical trial.
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Phase 3 was successful in meeting its primary and secondary goals and involved the enrollment of 564 patients, evaluated among three groups; BRCA mutant (BRCAmut+), HRD positive inclusive of BRCAmut+, and all patients treated.
Jonathan Ledermann, Professor of Medical Oncology and Clinical Director at the the University College London (UCL) Cancer Institute, has said that this approval will be “an important milestone for physicians and their patients with recurrent ovarian cancer because it offers them greater flexibility to use this novel PARP inhibitor, which has demonstrated significant clinical efficacy and has been well received in practice.”
In February 2018, RUBRACA was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Ovarian Cancer as a category 2A treatment.
Shares of Clovis Oncology had gone up by nearly 6% since that market opened and closed at $55.52 USD.
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