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FDA Approves AstraZeneca Ovarian Cancer Drug
From the Wall Street Journal of Fri, 19 Dec 2014 20:01:53 EST

In what regulators called the latest advance in the development of personalized medicine, the U.S. Food and Drug Administration on Friday approved the first drug to treat cases of ovarian cancer linked to specific genetic mutations.

The drug, made by AstraZeneca PLC, was approved for women with defective genes, known as BRCA1 and BRCA2, who have advanced ovarian cancer. The mutations, first discovered in the mid-1990s, are linked to as many as 15% of all ovarian cancers and up to 10% of all breast cancers. Last year, actress Angelina Jolie —whose mother died after a battle with ovarian cancer—said she underwent a preventive double mastectomy after testing positive for the BRCA1 mutation.

Though genetic tests to identify the mutations have long been used to predict the risk of cancer, until Friday there hadn’t been any approved therapies specifically for patients with BRCA-related disease.

The FDA approved AstraZeneca’s drug, called Lynparza, in conjunction with a companion diagnostic made by Myriad Genetics Inc. to test for BRCA mutations before doctors prescribe the treatment.

Lynparza “is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment,” Richard Pazdur, director of the FDA’s cancer drug division, said in a statement.

The FDA cleared Lynparza, known by the generic name olaparib, under a mechanism known as accelerated approval, which allows treatments to go on the market before they’ve been proven safe and effective in late-stage clinical trials. In a mid-stage study, tumors in 34% of patients taking the drug shrank. Continued approval of the drug is contingent on verification of the drug’s benefit in late-stage studies, the FDA said.

London-based AstraZeneca originally began development of Lynparza with the aim of treating a large majority of patients with ovarian and breast cancers, not just those with BRCA mutations. In 2011, the company nearly abandoned the drug after its effects in a broad patient population proved underwhelming. However, the company later conducted additional study data analyses and, using archived blood and tumor tissue samples, discovered the benefit in BRCA patients was larger than in the general population.

Lynparza’s approval is the first for a class of drugs called PARP inhibitors. The drugs were hoped to be capable of treating most ovarian and breast cancers, but many large drug makers, including Pfizer Inc. and Merck & Co., sold off rights to the drugs after it became clear the market opportunity would be smaller than anticipated.

In recent years, biotechnology companies including BioMarin Pharmaceutical Inc. and Clovis Oncology Inc. have taken up development of PARP inhibitors for BRCA patients. The drugs work by inhibiting production of an enzyme responsible for DNA repair, which scientists believe helps prevent tumor cells from repairing themselves. The drugs are thought to work better in BRCA patients because the mutations also interfere with DNA-repair.

AstraZeneca initially sought approval for the drug to treat patients with earlier-stage cancer as a so-called maintenance therapy, to prevent relapses in patients whose tumors had gone into remission after chemotherapy. An FDA advisory committee in June recommended against approval until the company completed late-stage studies. Committee members voiced concerns about the drug’s side effects, including rare occurrences of additional cancers, and a lack of proof the drug extended patients’ lifespans.

The FDA on Friday approved the drug only in the worst-off patients, based on AstraZeneca’s revised approval application following the advisory committee. Rather than be used as a maintenance therapy between chemotherapy treatments, the drug will be used by itself in patients whose tumors have stopped responding to chemotherapy, Jane Robertson, clinical director of Lynparza’s development program, said in an interview.

The European Union this week, approved Lynparza as a maintenance therapy in ovarian cancer patients.

“Olaparib has had ups and downs along the way, but finding the right patient population has been the key thing,” Ms. Robertson said, using the drug’s generic name.

Write to Joseph Walker at

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