FDA Grants Expanded Approval to AstraZeneca’s Lynparza (Olaparib)

By Joyce Bichler, Deputy Director

Today the Food and Drug Administration (FDA) expanded the approved use of the drug olaparib (brand name Lynparza). Olaparib is the first drug of its class (PARP inhibitor) approved to treat HER2-negative metastatic breast cancer in patients with a BRCA gene mutation and who have previously been treated with chemotherapy.

The approval of this drug was based on a randomized clinical trial of only 302 patients. Tumors in patients taking the drug did not have significant growth for a somewhat longer period of time (7 months vs. 4.2 months) than in patients not taking the drug. While extending someone’s progression free survival when they have metastatic breast cancer, even for 2.8 months is absolutely significant, we still don’t know if patients actually live any longer on this drug or not. There was no overall survival data reported.

Olaparib is a drug that also comes with significant side effects, including blood or bone marrow cancers. Other side effects include a list of symptoms that can severely impact  a person’s general quality of life—like nausea, fatigue, headache, and anemia. Thirty-six percent of the olaparib patients had grade 3 or higher adverse effects, which was slightly lower than the standard therapy group.

The cost of treatment is not insignificant—estimated to be about $14,000. We absolutely want to see more innovative treatments that focus on women with metastatic breast cancer—because that’s what women die from—and treatments that are matched to genetic types like BRCA mutations. However, we can’t be content or call this a big breakthrough when the impact on patients will be measured in days, while the advantage to the pharmaceutical company will be measured in millions of dollars.

Breast Cancer Action has long held that the FDA should only approve therapies that have been shown to improve overall survival (which means women live longer), improve quality of life (which means they live better), or cost less (so that more women have access and/or aren’t bankrupted by treatment).

By approving a treatment that has not been shown to extend life, significantly reduce side effects, or increase access, the FDA is giving license to AstraZeneca to make millions of dollars on a drug before its benefit to patients has been adequately demonstrated.

At best, let’s call this a small step forward. Let’s stop lowering the bar for what we call big breakthroughs. We want to celebrate the day when we have them. Today is not that day.

This entry was posted in Articles, BCA News.

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