The US Food and Drug Administration (FDA) has granted priority review for AstraZeneca‘s new drug application (NDA) of olaparib for treatment of ovarian cancer.
Olaparib is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits DNA repair pathway deficiencies to preferentially kill cancer cells.
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The drug is being reviewed in ovarian cancer patients who have a BRCA mutation and whose cancer has relapsed following a complete or partial response to platinum-based chemotherapy.
AstraZeneca said that patients with the BRCA mutation are being identified via a companion diagnostic test.
Priority review status means that the FDA intends to take action on the olaparib application within six months (compared with ten months under standard review) with a Prescription Drug User Fee Act (PDUFA) date of 3 October 2014.
The NDA was based on a randomised, double-blind, placebo-controlled Phase II trial, which assessed maintenance treatment with olaparib 400mg twice daily versus placebo in platinum-sensitive relapsed serous ovarian cancer patients.
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By GlobalDataThe trial evaluation of olaparib was carried out in patients who had received previous treatment with at least two platinum regimens and were in a maintained partial or complete response following their last platinum regimen.
The trial’s primary endpoint was progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and secondary endpoints included time to progression by cancer antigen-125 or RECIST, overall survival and safety.
AstraZeneca president of UK and Ireland Lisa Anson said the company has a strong commitment to cancer as a core therapy area.
"We continue to work closely with NICE and the NHS to ensure that ovarian cancer patients in the UK can benefit from this treatment should it be approved in Europe," Anson said.
In September 2013, the European Medicines Agency (EMA) accepted AstraZeneca’s marketing authorisation application for olaparib.
If approved by regulatory authorities, the drug would be the first PARP inhibitor for patients with BRCA mutated platinum-sensitive relapsed ovarian cancer.
Image: A very large ovarian cancer as seen on CT. Photo: courtesy of James Heilman.
