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AstraZeneca.

AstraZeneca achieved positive results from its Phase III OlympiAD trial comparing LYNPARZA (olaparib) tablets (300mg twice daily) to standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations. Patients treated with LYNPARZA showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin).

Initial findings from the OlympiAD study indicate that the safety profile of LYNPARZA was consistent with previous studies.

A full evaluation of the OlympiAD data is ongoing. AstraZeneca will be working with regulatory authorities to make LYNPARZA available to patients with this type of breast cancer.

LYNPARZA tablets are an investigational formulation not currently FDA-approved for any use. LYNPARZA capsules (400mg twice daily) are currently approved in the U.S. as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The indication is approved under accelerated approval based on objective response rate and duration of response.

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Title Annotation:Phase III
Publication:Contract Pharma
Date:May 1, 2017
Words:175
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