Treatment for BRCA-Mutated Breast Cancer Makes Another Regulatory Hurdle in the EU

According to a story from, the pharmaceutical companies Merck and AstraZeneca recently announced that the marketing application for the investigational drug olaparib (brand name Lynparza) was recently certified for review by the European Medicines Agency (EMA). The two companies have been working in collaboration to develop the new medication, which is designed to treat HER2 negative BRCA mutated metastatic breast cancer.
BRCA-mutated breast cancer generally makes up a fairly small proportion of reported breast cancer cases, around five to ten percent. Certain mutations in the BRCA1 and BRCA2 genes are responsible for dramatically increasing the likelihood of developing breast cancer in affected women. These mutations also greatly increase the risk of ovarian cancer as well. To learn more about BRCA-mutated breast cancer, click here.

Olaparib is meant for patients that have already attempted chemotherapy treatment for their cancer. Olaparib utilizes a unique mechanism of action that allows it to be particularly effective in patients with cancer linked to BRCA mutations. The treatment is classified as an poly-ADP ribose polymerase, or PARP, inhibitor. This means that olaparib is able to take advantage of the characteristics of the mutations in order to destroy cancer cells. If the drug gains approval, it would be the first drug of this type to be approved in the EU for treating breast cancer. Olaparib has already received approval from the U.S. FDA for BRCA-mutated breast cancer.

The medication is also meant for treating late stage metastatic breast cancer, or cancer that has begun to spread to other areas of the body. Currently, there are few effective treatment options for patients whose breast cancer has spread, and the five-year survival rate of metastatic breast cancer is only about 26 percent. As a result, there is a great need for more treatment options for metastasized cancer that can offer patients greater long term survival.

AstraZeneca and Merck first began their partnership to develop the new treatment in July of 2017. The two companies are also partnering to develop another anticancer agent called selumetinib, which is an MEK inhibitor. These two drugs utilize distinct operative mechanisms that should enable them to work against multiple types of rare cancer that does not always respond to conventional therapies.

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