The FDA said Friday that it has expanded the label for AstraZeneca's oral PARP inhibitor Lynparza (olaparib) to include the treatment of patients with metastatic breast cancer whose disease is associated with a BRCA gene mutation. The agency, which assessed AstraZeneca and partner Merck & Co.'s filing under a priority review, noted that the decision makes Lynparza the first drug in its class approved for breast cancer, and also that it is the first time any drug has been approved specifically to treat BRCA-mutated breast cancer.
Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, commented "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." He suggested the "approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types."
Approval of the new indication was backed by data from the Phase III OLYMPIAD trial of 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations. Results showed that median progression-free survival in the Lynparza arm was 7 months, compared to 4.2 months for patients taking chemotherapy only.
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The FDA noted that breast cancer patients will be selected for treatment with Lynparza based on Myriad Genetics' BRACAnalysis CDx test.
Lynparza is already approved in the US for women with BRCA-mutated, advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy, as well as for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumours have at least partially responded to chemotherapy.
In July 2017, AstraZeneca and Merck agreed to enter a global partnership worth as much as $8.5 billion to develop and market Lynparza for multiple oncology indications, including breast, prostate and pancreatic cancers. For related analysis, read ViewPoints: Will AstraZeneca's decision to cuddle up with Merck & Co. be justified?
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