AstraZeneca's PARP Inhibitor Lynparza Granted Orphan Drug Designation in Japan for gBRCA-Mutated Metastatic Pancreatic Cancer, Already Approved in the U.S.
Mar 21, 2020 11:37
CST Updated
11:37
AstraZeneca
Biopharmaceutical Manufacturer
March 21, 2020/BioValleyBIOON/--AstraZeneca(AstraZeneca) recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation (ODD) to the anticancer drug Lynparza (Chinese brand name: Lipuzhuo; generic name: olaparib) for the maintenance treatment of unresectable metastatic pancreatic cancer with germline BRCA mutations (gBRCAm). Lynparza is jointly developed and commercialized by AstraZeneca and Merck & Co.
Pancreatic cancer has the lowest survival rate among the most common cancer types and is the only major cancer type with a 5-year survival rate below 10% in nearly all countries.Results from the Phase III POLO study demonstrated that, compared with placebo, Lynparza nearly doubled 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%. The safety and tolerability profile of Lynparza in this trial was consistent with previously observed data.
Based on these study results, in late December 2019, Lynparza received U.S. FDA approval for first-line maintenance treatment in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. Notably, Lynparza is the only PARP inhibitor approved for the treatment of gBRCAm metastatic pancreatic cancer. Currently, the application for this indication is under regulatory review by the European Union and other jurisdictions.
In Japan, a drug is granted orphan drug designation by the MHLW if it is developed to treat diseases affecting fewer than 50,000 patients and for which there is a high unmet medical need. Japan has the fifth-highest incidence rate of pancreatic cancer worldwide, with 43,000 new cases diagnosed in 2018. Pancreatic cancer is the fourth leading cause of cancer-related death in Japan, resulting in 37,000 deaths in 2018.
AstraZenecaTumorJosé Baselga, Executive Vice President of Research and Development, stated, “Japan has the fifth-highest incidence rate of pancreatic cancer worldwide, and therapeutic progress for patients has been limited over the past few decades. This designation marks a significant milestone as Japan’s first step toward using targeted therapies in patients with advanced pancreatic cancer selected based on biomarker screening.”
Lynparza (Olaparib): Launched in China and included in the National Reimbursement Drug List
Pancreatic cancer is the 12th most common cancer type and the seventh leading cause of cancer-related deaths worldwide. It has the worst survival rate among the most common cancers, with a 5-year post-diagnosis survival rate in the single digits (2–9%) in every country. Early diagnosis of pancreatic cancer is challenging, as patients are typically asymptomatic until the disease progresses to an advanced stage. Approximately 80% of patients are diagnosed at the metastatic stage, with a median survival time of less than one year. Over the past few decades, pancreatic cancerDiagnosisThere has been little progress in treatment, with current therapies consisting of surgery (applicable to only 10–20% of patients), chemotherapy, and radiotherapy, highlighting a critical unmet need for more effective therapeutic options. Globally, approximately 460,000 new cases were diagnosed in 2018, with germline BRCA-mutated (gBRCAm) pancreatic cancer accounting for 5–7% of all cases.
Lynparza was approved in the United States in December 2014FDAApproved for marketing, 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 wide range of tumors with DNA repair defects. PARP is associated with a wide variety of tumor types, especiallyBreast Cancerand ovarian cancer. Currently, AstraZeneca is conducting multiple clinical studies to investigate the use of Lynparza in a wide range ofTumorpotential, including breast cancer, prostate cancer, and pancreatic cancer.
In July 2017, Merck & Co. andAstraZeneca Reaches Global Strategic Collaboration in Oncology to Co-Develop and Commercialize Lynparza and Another MEK Inhibitor, Selumetinib, for the Treatment of Multiple Cancer TypesTumor。
In the Chinese market, Lynparza (Lynparza) was approved by the China National Medical Products Administration (CNDA) 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 ovarian cancer treatment in China into the era of PARP inhibitors.
In early December 2019, Lynparza (Olaparib) was once again approved for first-line maintenance treatment in 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)