New FDA Approved Indication for LYNPARZA® (olaparib)

AstraZeneca recently announced that the US Food and Drug Administration (FDA) has approved a new indication for LYNPARZA® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

LYNPARZA is the FIRST and ONLY PARPi approved in combination with abiraterone plus prednisone or prednisolone (abi/pred) as initial therapy for BRCAm mCRPC.

FDA approval was based on the results from the PROpel phase 3 trial, which was presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and published in the journal NEJM Evidence (New England Journal of Medicine Group).

This is the eighth indication approved for LYNPARZA in the US.

For more information regarding the approval, please see AstraZeneca’s press release announcing the news.

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