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FDA Approves Lynparza as Adjuvant Therapy With Myriad Genetics CDx for BRCA-Mutated Breast Cancer

NEW YORK – The US Food and Drug Administration on Friday approved AstraZeneca and Merck's Lynparza (olaparib) as an adjuvant treatment for early-stage breast cancer patients harboring germline BRCA1/2 mutations.

In order to be eligible for the PARP inhibitor, women must have high-risk HER2-negative breast cancer that has been surgically removed and already received chemotherapy.

Simultaneously, with the drug approval, the FDA also approved Myriad Genetics' BRACAnalysis CDx as a test to identify patients with germline BRCA1/2 mutations who are eligible for treatment. 

The approval marks the first time the agency has approved a drug for early-stage breast cancer patients with BRCA1/2 mutations. The FDA approved the treatment based on data from the Phase III OlympiA trial, in which Lynparza-treated patients had a 42 percent lower risk of invasive breast cancer recurrences, second cancers, or death compared to those in the placebo arm.

Researchers presented these data at the American Society of Clinical Oncology's annual meeting last June. The data were compelling enough that ASCO updated its practice guidelines, well ahead of the FDA approval, recommending oncologists prescribe Lynparza for one year to high-risk BRCA1/2-mutated early-stage breast cancer patients after they've gotten chemo in the neoadjuvant or adjuvant setting.

Updated results from OlympiA, which researchers will present at an upcoming meeting, showed a survival advantage with adjuvant Lynparza treatment, with the PARP inhibitor reducing the risk of death by 32 percent compared to placebo.

Most breast cancer patients in the US are diagnosed with early-stage disease, and between 5 percent and 10 percent have inherited BRCA1/2 mutations, known to increase the risk of breast, ovarian, and other cancers. Although most early-stage patients do well on available therapy, those with BRCA1/2 mutations are at higher risk of relapse and in need of new treatment options, according to Andrew Tutt, global chair of the OlympiA trial and professor of oncology at the Institute of Cancer Research in London.

"OlympiA has shown that identifying a BRCA1/2 mutation in women with high-risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients," Tutt said in a statement.

The data from OlympiA sparked debate among practitioners as to whether genetic testing guidelines needed to be updated to ensure that all early-stage breast cancer patients could be tested for BRCA1/2 mutations to determine their inherited cancer risk as well as eligibility for the PARP inhibitor. "These data underline the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said in a statement.

The latest guidelines from the National Comprehensive Cancer Network recommend testing patients for BRCA1/2 germline mutations "to aid in adjuvant treatment decisions with olaparib for high-risk HER2-negative breast cancer."

Lynparza is already approved in the US, EU, Japan, and other countries as a treatment for metastatic breast cancer patients with germline BRCA1/2 mutations who have received chemo. In 2018, the FDA also approved this indication alongside Myriad's BRACAnalysis CDx to identify best responders.

Under a 2017 codevelopment and commercialization deal between Lynparza's sponsors, the latest approval triggers a $175 million regulatory milestone payment from Merck to AstraZeneca. The payment will be recorded by AstraZeneca as collaboration revenue during Q1 2022.