Certain cancer patients now have access to a new treatment option and companion diagnostic. On March 11, the U.S. Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for treating adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.
More specifically, the drug is approved for the adjuvant treatment of those patients who have also been treated with neoadjuvant or adjuvant chemotherapy, according to the FDA. To receive the new treatment, patients must be chosen based on an FDA-approved diagnostic for olaparib.
The FDA granted approval based on a randomized, double-blind, placebo-controlled, international study—known as OlympiA—of 1,836 patients with gBRCAm HER2-negative high-risk early breast cancer who completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
According to information on the Lynparza website, the drug had previously been approved for use in certain patients with advanced ovarian cancer, metastatic prostate cancer, metastatic pancreatic cancer, and metastatic breast cancer. It is being commercialized by both AstraZeneca and Merck.
The Companion Diagnostic
On the same day as olaparib was approved for its new use, the FDA also approved Myriad Genetics’ BRACAnalysis® CDx test to be used as a companion diagnostic to determine which breast cancer patients would benefit from the drug. According to a press release from the company, the test aims to find and interpret BRCA1 and BRCA2 variants, identifying deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer.
“Studies have demonstrated that PARP inhibitors [the type of cancer drug that includes olaparib] are highly effective in patients with BRCA1/BRCA2 mutations. Once we identify these patients, they will have more options for treatment,” said Thomas Slavin, MD, chief medical officer, Myriad Genetics, in a statement. “This important advancement underscores the need for breast cancer patients being evaluated for approved therapies to know their BRCA status with an FDA-approved test right after diagnosis to help ensure they will receive the best available therapy.”