LYNPARZA Maintenance Therapy: The Only PARPi FDA-approved in First-line Maintenance for Women with BRCAm*

LYNPARZA Maintenance Therapy: The Only PARPi FDA-approved in First-line Maintenance for Women with BRCAm* Advanced Ovarian Cancer in Complete or Partial Response to Platinum-based Chemotherapy

Presented by

THOMAS KRIVAK, MD

RSVP is required by 07/26/2019.

To register or for more information, contact

Katie Naylor at katie.naylor@astrazeneca.com or (203) 980-2353

*An FDA-approved test for the detection of tumor BRCA gene mutation for the first-line maintenance treatment of advanced † ovarian cancer is not currently available. 1

As determined by an FDA-approved companion diagnostic.

INDICATION

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly

until recovery.