FDA Expands Indication of Anti-Cancer Drug to Include Genetic-Based Breast Cancer

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The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.

On Jan. 12, 2018, FDA announced that it has expanded approval of AstraZeneca’s Lynparza (olaparib) to treat types of breast cancer that have spread and whose tumors have a specific inherited genetic mutation, making it the first drug in its class approved to treat breast cancer. According to FDA, this is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation.

Approximately 20-25% of patients with hereditary breast cancers and 5-10% percent of patients with any type of breast cancer have a BRCA mutation, according to an agency press release. BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including breast cancers.

Lynparza is a poly ADP-ribose polymerase inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.

The drug first received agency approval in 2014 for the treatment of patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy, and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy.

“This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in the release. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”


Recipients of the new treatment are chosen using an FDA-approved genetic test called the BRACAnalysis CDx, which was developed by Myriad Genetic Laboratories. As of the date of the press release, the agency has expanded the approval of the BRACAnalysis CDx to include the detection of BRCA mutations in blood samples from patients with breast cancer.

In July 2017, AstraZeneca and Merck & Co. announced that they entered a collaboration to co-develop and co-commercialize Lynparza for multiple cancer types, which generated sales of $218 million in 2016.

Source: FDA, AstraZeneca