Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy.

In August 2019, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza for this indication with Priority Review and set a Prescription Drug User Fee Act (PDUFA) date for the fourth quarter of 2019.

José Baselga, Executive Vice President, Oncology R&D, said: “We are pleased with the ODAC’s recommendation for Lynparza and the potential to bring a personalised, biomarker-targeted medicine to patients with germline BRCA-mutated metastatic pancreatic cancer. Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. We look forward to working with the FDA as it completes the review of our application.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “We are encouraged by the ODAC’s favourable vote for Lynparza as a 1st-line maintenance therapy in germline BRCA-mutated metastatic pancreatic cancer. This recommendation is a significant step towards reaching our goal to help patients with this deadly disease.”

The sNDA submission was based on the positive results from the Phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting. The results showed a statistically significant and clinically meaningful improvement in progression-free survival and reduced the risk of disease progression or death by 47% based on a hazard ratio of 0.53 (p=0.0038). Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo.

The benefit of maintenance with Lynparza was seen consistently across a range of clinically meaningful endpoints. At each time point, from six months onwards, more than twice as many patients treated with Lynparza showed no disease progression vs. those on placebo. In patients with measurable disease at baseline, 23% responded to Lynparza vs.12% on placebo and had a median duration of treatment in excess of two years (24.9 months) vs 3.7 months on placebo. Overall survival (OS), a secondary endpoint, at interim analysis was 18.9 months for Lynparza vs. 18.1 months for placebo but did not reach statistical significance (HR=0.90; p=0.68). The safety and tolerability profile of Lynparza in the Phase III POLO trial was in line with that observed in prior clinical trials.

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and potential new medicines for use in the treatment of cancer. The FDA will consider the vote as it reviews the submission and is not bound by the Committee’s recommendation.

In addition to the US, Lynparza is currently under regulatory review in the EU, Canada and other jurisdictions as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer.

Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the US. The FDA granted Lynparza Orphan Drug Designation in October 2018, which is for medicines intended to treat, diagnose or prevent rare diseases or disorders that affect fewer than 200,000 people in the US.

Lynparza was the first PARP inhibitor to be approved and has been used in over 25,000 patients worldwide. Lynparza is currently approved in 65 countries including the US for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. It is approved in the US, the EU, Japan and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 44 countries, including the US and Japan, for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer.



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