Boost for Clovis as FDA grants priority review for rucaparib in ovarian cancer
pharmafile | August 25, 2016 | News story | Research and Development, Sales and Marketing | FDA, clovis, ovarian cancer, rucaparib
Clovis Oncology has announced that the US Food and Drug Administration has accepted its new drug application for rucaparib, and granted it priority review, for patients with advanced ovarian cancer.
A decision date of February 23rd 2017 has been set for when a decision will be made on the drug, which has shown promise for the treatment of ovarian cancer in patients with deleterious BRCA-mutated tumours, inclusive of both germline and somatic BRCA mutations, and who have been treated with two or more chemotherapies.
The news is a timely boost for Clovis, after cutting 35% of its workforce following the FDA’s rejection of its lung cancer candidate, rociletinib.
As part of its submission for rucaparib, Clovis has included trial data which shows objective response rates of 54%, complete response of 9% and a median duration of response of 9.2 months.
Robert Coleman, MD, one of the principle investigators on the trial, comments: “Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumours have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients.”
Patrick Mahaffy, CEO of Clovis Oncology, says: “The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis. There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”
Sean Murray
Related Content
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
MedPharm announces US FDA inspection of North Carolina manufacturing facility
MedPharm has announced that the US Food and Drug Administration (FDA) has completed a successful …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
