The US Food and Drug Administration (FDA) approves a new indication for LYNPARZA®
The US Food and Drug Administration (FDA) has approved a new indication for LYNPARZA® (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
LYNPARZA is the first and only targeted adjuvant therapy with an FDA-approved indication specifically for patients with gBRCAm,* HER2-negative, high-risk† early breast cancer for patients who have been treated with neoadjuvant or adjuvant chemotherapy.
FDA approval was based on the results from the OlympiA phase 3 trial, which was presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
Please see the attached documents for more information regarding the use of LYNPARZA in this new indication:
READ FULL PRESS RELEASE HERE
Lynparza Fact Sheet
Lynparza - Testing Recommendations
Examples of Lynparza Treatment Plan
Regards,
Randy
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Randy Niemeyer
National Account Director - Oncology
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AstraZeneca
(Home Office) 573-324-0101; (Mobile) 573-268-8787
randall.niemeyer@astrazeneca.com