AstraZeneca ovarian cancer drug approved in Europe
pharmafile | December 18, 2014 | News story | Sales and Marketing | AstraZeneca, BRCA, Cambridge, Cancer, FDA, lynparza, olaparib, ovarian
The European Commission has approved AstraZeneca’s Lynparza for the treatment of advanced BRCA-mutated ovarian cancer.
Lynparza (olaparib) has been approved for use with patients who are in complete or partial response to chemotherapy and to treat adult patients with relapsed ovarian, fallopian tube, or primary peritoneal cancers.
“We are delighted to be able to bring this much needed treatment to patients with BRCA-mutated ovarian cancer whose options are currently very limited.
“Today’s approval marks a significant milestone in the development of the next generation of targeted medicines,” says Briggs Morrison, executive vice president, global medicines development and chief medical officer at AstraZeneca.
The drug failed to win US approval back in May after concerns were raised about Lynparza’s risk-benefit profile. Now news source Reuters predicts that the EU nod has potential to make the firm $2 billion in annual sales.
The UK pharma giant will await to hear back from the Food and Drug Administration regarding US approval early next year.
In Europe alone ovarian cancer is the fifth most commonly diagnosed cancer in women and the sixth leading cause of cancer deaths in females. Up to 15% of women with ovarian cancer have a BRCA mutation.
High-risk mutations like BRCA disable an important error-free DNA repair process which significantly increases the risk of developing breast cancer, ovarian cancer and certain other cancers.
University of Cambridge scientist Professor Steve Jackson, whose research established the basis for olaparib and its clinical potential says: “It is wonderful to learn that olaparib is set to become a licensed drug and will therefore soon become available to advanced ovarian cancer sufferers. I also look forward to learning the results of ongoing trials exploring olaparib’s potential for the treatment of other cancers.”
In addition to ovarian cancer AZ is also investigating the full potential of the drug in multiple tumour types, with Phase III studies in second line gastric cancer, pancreatic cancer and adjuvant and metastatic breast cancers underway.
Tom Robinson
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