FDA Approves AstraZeneca and Merck’s Lynparza for Pancreatic Cancer

FDA Approves AstraZeneca and Merck’s Lynparza for Pancreatic Cancer

AstraZeneca and Merck announced the U.S. FDA has approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

The FDA approval of Lynparza was based on results from the pivotal Phase III POLO trial, which were published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting. Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where 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 safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.

AstraZeneca and Merck & Co., Inc., entered into a global strategic oncology collaboration in March of 2017 to co-develop and co-commercialize Lynparza.

About Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.

Lynparza is currently approved in 65 countries for breast and ovarian cancer. 

About pancreatic cancer

Pancreatic cancer is the 12th most commonly occurring cancer and the 7th leading cause of cancer death globally. The disease has the lowest survival rate of the most common cancers and is the only major cancer with a single-digit five-year survival rate (2-9%) in nearly every country. There were approximately 460,000 new cases worldwide in 2018. As there are often no symptoms, or symptoms may be non-specific in the early stages, it is commonly diagnosed at an incurable stage. Around 80% of pancreatic cancer patients are diagnosed when the disease has metastasized and for these the average survival is less than a year. Despite advances in treatment, few improvements have been made in diagnosis and treatment over the decades. Current treatment is surgery (for which approximately only 10-20% of patients are eligible), chemotherapy and radiotherapy, highlighting a critical unmet medical need for more effective treatment options.