Lynparza Approved by the US Food and Drug Administration for the Treatment of Advanced Ovarian Cancer in Patients with Germline BRCA mutations

(WILMINGTON, DEL) AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA™ (olaparib) capsules.

LYNPARZA is the first poly ADP-ribose polymerase (PARP) inhibitor indicated as 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. LYNPARZA has been approved under the FDA's Accelerated Approval program, based on objective response rate and duration of response data. Continued approval for this indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials.

There are no contraindications for LYNPARZA. Warnings and precautions include myelodysplastic syndrome/acute myeloid leukemia, pneumonitis and embryo-fetal toxicity (see Important Safety Information below).

Dr. Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said "LYNPARZA is an excellent example of how advances in the understanding of cancer biology can be used to develop targeted medicines. It is a much-needed new therapeutic option for patients with germline BRCA -mutated advanced ovarian cancer."

The FDA approval is based on efficacy data from a single-arm Phase II study of LYNPARZA in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as well as safety data from several other studies, including a placebo-controlled study. The efficacy of LYNPARZA is based on analysis of 137 patients with measurable, germline BRCA mutated-advanced ovarian cancer treated with three or more prior lines of chemotherapy. The trial results demonstrated an overall response rate of 34% (95% CI: 26%, 42%; complete response 2%, partial response 32%). The median duration of response was 7.9 months (95% CI: 5.6, 9.6 months). The most common adverse reactions reported have been generally mild to moderate and have included nausea, vomiting, fatigue and anaemia (see Important Safety Information below).

Dr. Ursula Matulonis, Associate Professor of Medicine, Harvard Medical School and Director of the Gynecologic Oncology Program at Dana-Farber Cancer Institute in Boston, MA, said: "Ovarian cancer is diagnosed in nearly 22,000 women per year. The long-term survival rate in patients with advanced ovarian cancer is 10% to 30%. The FDA approval of LYNPARZA is a significant milestone for our patients as currently there are only limited treatment options available to women with ovarian cancer who carry the BRCA mutation."

Concurrent with the approval of LYNPARZA, the FDA has approved the BRACAnalysis CDx™ (Myriad Genetic Laboratories) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes.