Lynparza (Olaparib) Receives EU Approval as First-Line Maintenance Therapy for gBRCAm Metastatic Pancreatic Cancer

July 09, 2020 /BioonBIOON/ --AstraZeneca(AstraZeneca) and Merck & Co. recently announced jointly that the European Commission (EC) has approved the targeted anticancer drug Lynparza (Chinese brand name: Lipzhuo, generic name: olaparib, olaparib tablets) for first-line maintenance treatment of patients with metastatic pancreatic cancer carrying germline BRCA mutations (gBRCAm). Specifically, it is indicated for adult patients with metastatic pancreatic cancer who carry germline BRCA1/2 mutations and whose disease has not progressed after receiving at least 16 weeks of platinum-based chemotherapy as part of a first-line chemotherapy regimen.

Notably, Lynparza is the only PARP inhibitor approved for the treatment of germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. In the United States, Lynparza was approved in December 2019FDAApproved for first-line maintenance treatment of adult patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. Regulatory reviews of Lynparza are ongoing in other jurisdictions, excluding the United States, the European Union, and several other countries.

This latest approval is based on the results of the Phase III POLO trial. The relevant data have been published in The New England Journal of Medicine (NEJM). The trial demonstrated that, compared with placebo, Lynparza as first-line maintenance therapy nearly doubled the progression-free survival (PFS) in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer (median PFS: 7.4 months vs. 3.8 months) and significantly reduced the risk of disease progression or death by 47%. In this trial, the safety and tolerability profile of Lynparza was consistent with that observed in previous studies.

Hedy L. Kindler, Professor of Medicine at the University of Chicago and Co-Principal Investigator of the POLO study, stated, “Today’s approval opens a door by providing biomarker-guided care for patients with metastatic pancreatic cancer in the European Union, the region with the highest incidence of pancreatic cancer globally. Lynparza now offers clinicians a targeted, well-tolerated treatment option for metastatic pancreatic cancer with germline BRCA mutations.”

AstraZenecaTumorDave Fredrickson, Executive Vice President of Business Operations, stated, “Metastatic pancreatic cancer is an aggressive disease with little therapeutic progress made over the past few decades. In the POLO trial, patients with gBRCAm pancreatic cancer who received Lynparza after first-line chemotherapy had a median progression-free survival (PFS) that was nearly twice that of placebo. This approval underscores the importance ofDiagnosis"...the importance of conducting germline BRCA mutation testing in all patients, as this will help provide personalized treatment options for patients in the EU."

Pancreatic cancer is a fatal malignancy with a very high unmet medical need. It is the 11th most common cancer type and the seventh leading cause of cancer-related deaths worldwide, exhibiting the poorest survival rate among the most common cancers. In every country, the 5-year survival rate after diagnosis is in the single digits (2–9%). Early diagnosis of pancreatic cancer is challenging; patients are typically asymptomatic until the disease progresses to an advanced stage, with approximately 80% of patients being diagnosed at the metastatic stage.Diagnosis...the average survival time for these patients is less than one year.

Pancreatic Cancer Over the Past Few DecadesDiagnosisThere has been little progress in treatment, with current therapeutic options primarily consisting of surgery (applicable to only 10–20% of patients), chemotherapy, and radiotherapy, highlighting a critical unmet need for more effective treatment regimens. Globally, approximately 460,000 new cases were diagnosed in 2018, with gBRCAm pancreatic cancer accounting for 5–7% of all cases.

Lynparza was approved in the United States in December 2014FDAApproved for market launch, becoming the first PARP inhibitor approved globally. Lynparza is a first-in-class, oral PARP inhibitor that selectively kills cancer cells by exploiting defects in DNA repair pathways. This mechanism of action gives Lynparza the potential to treat a broad range of tumors with DNA repair deficiencies. PARP is associated with a wide variety ofTumortype-related, especially breast cancer and ovarian cancer.

In July 2017, AstraZeneca and MSD reached a global strategic collaboration in oncology to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, for the treatment of a wide range ofTumor, including breast cancer, prostate cancer, and pancreatic cancer.

In the Chinese market, Lynparza (Lipuzhuo) was approved by the China National Medical Products Administration (NMPA) on August 23, 2018, for maintenance treatment of platinum-sensitive recurrent ovarian cancer. This approval made Lynparza the first targeted therapy approved for ovarian cancer in China, marking the entry of PARP inhibitors into the era of ovarian cancer treatment in the country.

In early December 2019, Lynparza (olaparib) was again approved for first-line maintenance treatment of patients with advanced ovarian cancer harboring BRCA mutations. Benefiting from China’s strong support for pharmaceutical innovation and the accelerated approval of new drugs urgently needed in clinical practice, Lynparza (olaparib) became the first PARP inhibitor approved in China for first-line maintenance therapy in ovarian cancer. On November 28, 2019, Lynparza (olaparib) was included in the National Reimbursement Drug List. (Bioon.com)

Original Source:Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer