• Monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

• Diagnosis of advanced ovarian cancer associated with defective BRCA genes

AND

• Failure or clinically significant adverse effects to three or more prior lines of chemotherapy (see therapeutic alternatives)

OR

• Prescribed by an oncologist

• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

• Lynparza's indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
• NCCN recommended use: Preferred single-agent therapy in patients with BRCA mutated genes for persistent disease or recurrence following three or more lines of therapy.
• NCCN targeted therapy for platinum-sensitive and platinum-resistant disease.
• Myelodysplastic syndrome/Acute Myeloid Leukemia (MDS/AML) have been confirmed in patients treated with Lynparza. Majority of the cases (17 of 22) were fatal. If MDS/AML is confirmed, discontinue Lynparza.
• The FDA approved Lynparza with a genetic test called BRACAAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian is available at http://www.fda.gov/companiondiagnostics

Capsule: 50 mg