New Indication approved by FDA for LYNPARZA® (olaparib)

Astra Zeneca announced that the US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.1

The approval was based on a biomarker subgroup analysis from the Phase III PAOLA-1 trial, published in The New England Journal of Medicine, which showed LYNPARZA in combination with bevacizumab reduced the risk of disease progression or death by 67% (equal to a hazard ratio of 0.33) and improved progression-free survival to a median of 37.2 months vs 17.7 months with bevacizumab alone. The safety and tolerability profile of LYNPARZA in the PAOLA-1 trial was generally consistent with previous trials.1

This is the sixth indication approved for LYNPARZA in the US, making it the only PARP inhibitor with two approvals in the US in the 1st-line maintenance setting for advanced ovarian cancer.1 (See Important Safety Information below).

Having this new treatment option for certain patients with advanced ovarian cancer addresses a continued unmet medical need for this patient population and further allows the treatment team to individualize patient care, expanding LYNPARZA’s use as a 1st-line maintenance treatment in combination with bevacizumab to women that are HRD-positive patients, which includes patients irrespective of BRCA mutation status.1

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

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

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