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FDA Approves First Treatment Targeting BRCA Mutations in Early Breast Cancer | by heidi


The Food and Drug Administration approved AstraZeneca’s Lynparza (olaparib) on March 11, 2022, for the additional treatment of adult patients with BRCA-mutated HER2-negative high-risk early breast cancer who have received treatment with chemotherapy/surgery.

According to the FDA, approval was based on findings from the OlympiA phase 3 trial—a randomized, placebo-controlled and international study of 1,836 patients with high-risk early breast cancer who completed local treatment and chemotherapy.1 Patients were randomly tasked to either take 300 mg of Lynparza tablets by mouth twice a day for 1 year or a placebo.

The study, which was published in the New England Journal of Medicine, found those who took Lynparza showed a 42% improvement in invasive disease-free survival versus the placebo group.2 In addition, the study showed Lynparza reduced the risk of death by 32% compared to the placebo.

 How Having a BRCA Mutation Affects Breast Cancer Risk

“This is a treatment approach to further reduce the risk of recurrence in this high-risk population. It is overall well tolerated because it is not chemotherapy,” Nancy Chan, MD, medical oncologist and the director of breast cancer clinical research at NYU Langone’s Perlmutter Cancer Center, told Verywell in an email. “Patients who received Olaparib in this setting had a 32% reduction in risk of recurrence compared to patients who did not receive Olaparib.”

Road to Approval 

Lynparza has previously been used as a treatment for some people who have advanced ovarian cancer, metastatic pancreatic cancer, and metastatic prostate cancer. It is used for people who have a certain type of inherited or abnormal gene called BRCA, which is a risk factor for cancer. The drug is also given to patients where cancer has come back or spread to other parts of the body after previously receiving chemotherapy.3

“Olaparib is not a brand new drug, it has been studied extensively in ovarian cancer, with good tolerability,” Chan said. “It is approved for ovarian cancer as well.”

 What Is Your Cancer Risk If You Have a BRCA2 Mutation?

The FDA has approved Lynparza capsules and tablets in previous years for the treatment of other types of cancers:

December 19, 2014: The FDA approved Lynparza to treat advanced ovarian cancer.

August 17, 2017: Tablet formulation of Lynparza for the treatment of ovarian cancer was approved.

January 12, 2018: The FDA approved Lynparza tablets for germline BRCA-mutated (gBRCAm) metastatic breast cancer.

December 30, 2019: Lynparza was approved by the FDA for the treatment of gBRCAm metastatic pancreatic cancer.

May 8, 2020: Lynparza+bevacizumab was approved for use in patients with advanced ovarian cancer.

May 19, 2020: FDA approved Lynparza as a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

March 11, 2022: Lynparza can be used for adjuvant treatment of high-risk early breast cancer.

What You Need to Know About Lynparza 

Lynparza is a non-chemotherapy medication that is taken orally in a pill form. The recommended dose is 300 mg twice daily, with or without food, for up to one year. However, your primary oncologist or doctor should give you clear instructions on when to take the medication and when to stop treatment.4

To receive this drug, patients must first have a known BRCA1 or BRCA2 mutation, which is an inherited breast/ovarian cancer mutation. These mutations can be detected through a genetic, blood, or saliva test, according to Monica Lee, MD, an oncologist at Providence St. Jude Medical Center’s Crosson Cancer Institute in California. 

Once that is known, Lee said patients then have to be classified as high-risk for disease recurrence, however, the criteria for this depends on whether a patient has triple-negative breast cancer or estrogen receptor-positive breast cancer.

As stated by AstraZeneca, only adults that meet the criteria defined by the FDA are eligible for this medication. “Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for Lynparza,” the company said in a statement. 

“If a patient has a known germline BRCA 1 or 2 mutation, the patient should speak to their oncologist regarding whether genetic counseling and testing is indicated based on several factors such as the subtype of breast cancer, age, and family history,” Chan added. 

 Non-BRCA Mutations That Raise the Risk of Getting Breast Cancer

At this time, it is not known if Lynparza is safe and effective in children.

How Lynparza Works In The Body

Lynparza is a drug that blocks poly (ADP-ribose) polymerase (PARP) proteins. PARP is a protein that helps cells repair themselves when they are damaged. Lynparza is considered to be a PARP inhibitor, which is a type of targeted therapy that stops these proteins from working. By blocking PARP, Lynparza may keep cancer cells from repairing their damaged DNA, causing cancer cells to die.5

“Olaparib belongs to a class of drugs called PARP inhibitors," Parvin Peddi, MD, medical oncologist and director of Breast Medical Oncology for the Margie Petersen Breast Cancer at Providence Saint John’s Health Center, told Verywell in an email. “If a patient with BRCA mutation has breast cancer with high-risk features (examples are larger triple-negative breast cancers or cancer in several lymph nodes despite chemotherapy), their doctor could prescribe a year of Olaparib to increase chances of cure.”

Limitations/Side Effects 

Taking Lynparza can cause some side effects, including:







Decreased appetite



But how often and how severe side effects are will vary from person to person. It can also depend on other treatments you’re having or medications you are taking.

“The treatment is well tolerated for the most part. There are some side effects including fatigue, mouth sores, and GI side effects like nausea, vomiting, diarrhea, but usually not severe,” Lee said. “Blood counts need to be monitored because the medication can lower your blood counts.”

Patients should contact their doctor or oncologist if they are experiencing severe side effects or if side effects are getting worse over time.

What This Means For You

Adult patients with BRCA1 or BRCA2 gene mutations who received previous treatment of chemotherapy/surgery should speak with their health care provider to see if they qualify for Lynparza.

Why FDA Approval Matters 

Approval from the FDA offers patients with a high risk of breast cancer recurrence a drug to improve odds that is not chemotherapy. Now, they can take an oral medication that is generally well-tolerated and taken for one year, Peddi said.

Chan added that approval is another important advancement in finding a more personalized approach to cancer therapy along with giving patients an additional tool to lower their risk of cancer.

“We are always cautious about adding more therapies/more medications to a patient’s treatment plan, as it will affect their quality of life,” Chan said. “However, the data... showed that adding olaparib to patients with BRCA 1 or 2 germline mutation who have completed their treatment (surgery/chemotherapy) was effective in lowering the risk of a recurrence.”

This approval not only adds additional treatment options that benefit more people but opens the door for more therapies that can be tailored to a particular subset of patients either due to their personal genetics or a particular signature in their cancer cells, Lee added.

Lynparza is approved for use in the U.S., European Union, Japan, and other countries.