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news.AstraZeneca has received approval from the European Commission (EC) for Lynparza (olaparib) capsules 400mg twice daily as the first therapy to treat adults with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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The drug is approved for patients who are in complete response or partial response to platinum-based chemotherapy.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA repair pathway deficiencies to kill cancer cells.
AstraZeneca executive vice-president Global Medicines Development and chief medical officer Briggs Morrison said: "Today’s approval marks a significant milestone in the development of the next generation of targeted medicines.
"We are committed to bringing new treatments to the patients who need them most and today’s news marks only the first of what we hope will be a number of indications in which Lynparza has the potential to transform the lives of cancer patients, including those with breast, pancreatic and gastric cancers."
The EC marketing authorization is applicable to all 28 EU member states as well as Norway, Iceland and Liechtenstein.
The approval was based on data from a Phase II trial (Study 191) which evaluated the efficacy and safety of olaparib compared to placebo in platinum-sensitive relapsed high grade serous ovarian cancer patients.
The trial showed that olaparib maintenance therapy significantly prolonged progression free survival (PFS) compared with placebo in patients with BRCA-mutated ovarian cancer: median PFS 11.2 months vs 4.3 months.
Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.