FDA Approves LYNPARZA in Germline BRCA-Mutated Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved LYNPARZA (olaparib) for use in patients with deleterious or suspected deleterious germline BRCA- mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2) – negative metastatic breast cancer who have been past history chemotherapy in the neoadjuvant, adjuvant or metastatic setting. The drug approval has declared by the AstraZeneca and Merck, known as MSD outside the United States and Canada.

Patients with hormone receptor-positive (HR+) bosom cancer should have been treated with an earlier endocrine treatment or be considered inappropriate for endocrine treatment. Patients are chosen for treatment based on an FDA- approved companion diagnostic from Myriad Genetics.

FDA Approves LYNPARZA In Germline BRCA-Mutated Metastatic Breast Cancer

Dave Fredrickson said, “This new approval for LYNPARZA (olaparib) makes it the first and only PARP inhibitor approved in germline BRCA -mutated metastatic breast cancer, and the only PARP inhibitor approved outside of ovarian cancer. This is significant for breast cancer patients, as the identification of BRCA status, notwithstanding hormone receptor and HER2 status, turns into a potentially basic step in the management of their disease.”

Dr. Roy Baynes said, “This additional approval for LYNPARZA, based on the compelling information from the OlympiAD trial, represents to a vital advance for women with germline BRCA- mutated HER2-negative metastatic breast cancer, which is a hard to treat disease”.

The approval based on information from the randomized, open-label, stage 3 OlympiAD trial, which explored LYNPARZA (olaparib) versus doctor’s decision of chemotherapy (capecitabine, eribulin or vinorelbine).

In the OlympiAD trial, LYNPARZA altogether prolonged progression-free survival (PFS) compared with chemotherapy and decreased the risk of disease progression or mortality rate by 42 percent (HR 0.58; 95% CI 0.43-0.80; P=0.0009 median 7.0 versus 4.2 months).

Patients experienced a targeted response rate with LYNPARZA (n=167) of 52% (95% CI 44-60), double the response rate for individuals in the chemotherapy arm (n=66), which was 23% (95% CI 13-35).

Furthermore, patients experienced a confirmed complete response rate of 7.8 percent for LYNPARZA compared with 1.5 percent for the chemotherapy arm. The information from the OlympiAD trial can be found in the June 2017 issue of the New England Journal of Medicine.

Dr. Susan M. Domchek said, “Patients diagnosed to have BRCA-related metastatic breast cancer are mostly younger than other breast cancer patients, and their disease is often significantly more aggressive and difficult to treat”.

“Currently there is no treatment for metastatic breast cancer, the present approval offers a new, targeted option that may delay disease progression for these patients.”

For BRCA mutations by undergoing genetic testing, we can gain critical data that will inform personalized treatment options particularly for women with this mutation.

In the OlympiAD trial who received LYNPARZA, the most common adverse drug reactions of patients were nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

In the U.S., for LYNPARZA (olaparib) this is the third indication approved where it has been used to treat almost 4,000 advanced ovarian malignancy patients.


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