17 January 2018 - - Wilmington, Delaware-based AstraZeneca and Kenilworth, New Jersey-based global healthcare solutions provider Merck (NYSE: MRK), known as MSD outside of the United States and Canada, have received US Food and Drug Administration approval for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, the companies said.
Patients with hormone receptor positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Patients are selected for therapy based on an FDA-approved companion diagnostic from Myriad Genetics.
The approval was based on data from the randomized, open-label, Phase III OlympiAD trial, which investigated Lynparza versus physician's choice of chemotherapy (capecitabine, eribulin or vinorelbine).
In the trial, Lynparza significantly prolonged progression-free survival compared with chemotherapy, and reduced the risk of disease progression or death by 42%. Patients with measurable disease taking Lynparza (n=167) experienced an objective response rate of 52%, double the response rate for those in the chemotherapy arm which was 23%. Additionally, patients experienced a confirmed complete response rate of 7.8% for Lynparza compared to 1.5% for the chemotherapy arm.
The most common adverse reactions in the OlympiAD trial of patients who received Lynparza were nausea, anemia, fatigue (including asthenia), vomiting, neutropenia, respiratory tract infection, leukopenia, diarrhea and headache.
This is the third indication approved for Lynparza in the US, where it has been used to treat nearly 4,000 advanced ovarian cancer patients.
Lynparza has a broad clinical development program, and AstraZeneca and Merck are working together to deliver Lynparza as quickly as possible to more patients across multiple settings, including breast, ovarian, prostate, and pancreatic cancers.
Lynparza is the first FDA-approved oral poly ADP-ribose polymerase inhibitor and the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
AstraZeneca is committed to advancing new oncology as one of its five growth platforms focused on lung, ovarian, breast and blood cancers. In addition, the company actively pursues innovative partnerships and investments.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology, cardiovascular, and metabolic diseases, and respiratory.
The company is also selectively active in the areas of autoimmunity, neuroscience, and infection. AstraZeneca operates in over 100 countries; its North American headquarters are located in Wilmington, Delaware.
Merck provides healthcare solutions worldwide through four segments: pharmaceutical, animal health, healthcare services, and alliances.
The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, physician distributors, veterinarians, distributors, animal producers, and managed health care providers.