Pancreatic cancer is a big news! AstraZeneca / mesardon lynparza (Lipitor) in the treatment of gbrcam pancreatic cancer was supported by the US FDA expert committee!

December 19, 2019 / BIOON / -- AstraZeneca and its partner Merck & Co recently jointly announced that FDA cancer According to the results of 7-5 votes, the Drug Advisory Committee (ODAC) proposed to approve the targeted anticancer drug lynparza (Chinese brand name: Lipitor, common name: olaparib, olapari), as a first-line maintenance monotherapy, for the treatment of metastatic pancreatic cancer patients with no progress after first-line platinum chemotherapy and BRCA mutation (gbrcam) of reproductive system In August 2019, FDA accepted lynparza's supplementary new drug application (SNDA) for the above indications and is conducting priority review The target date of PDUFA is the fourth quarter of 2019 Apart from the United States, lynparza's application for the indication is under regulatory review in the European Union, Canada and other jurisdictions "We are pleased that ODAC has recommended lynparza, which has the potential to bring an individualized biomarker targeted drug to patients with metastatic pancreatic cancer carrying a gbrca mutation," said Jos é baselga, executive vice president of oncology research and development at AstraZeneca In the past few decades, the prognosis of patients with advanced pancreatic cancer has been poor due to the invasive nature and limited treatment progress We look forward to working closely with the FDA in its review process " Roy Baynes, chief medical officer, senior vice president and director of global clinical development of moshadong research laboratory, said: "we are encouraged by the voting results of ODAC in support of lynparza as a first-line maintenance treatment for gbrca mutant metastatic pancreatic cancer This recommendation is an important step towards helping patients with this deadly disease achieve our goals " This SNDA submission is based on the positive results of polo in phase III clinical study The results were presented at the 2019 ASCO annual meeting in June and published in the New England Journal of Medicine (NEJM) It is worth mentioning that based on the results of this study, lynparza has become the only PARP inhibitor in the phase III study that has shown survival benefits in the treatment of gbrcam metastatic pancreatic cancer In the United States, the FDA has previously licensed lynparza as an orphan drug for pancreatic cancer Polo study is a randomized, double-blind, placebo-controlled, multicenter study It was carried out in 154 patients with metastatic pancreatic cancer who received first-line platinum chemotherapy without progress and carried germline BRCA mutation (gbrcam) The efficacy and safety of lynparza (300mg, twice a day) as a first-line maintenance monotherapy were evaluated In the study, patients were treated with lynparza or placebo in a 3:2 ratio until the disease progressed The primary end point of the study was progression free survival (PFS), and the key secondary end points included total survival (OS), secondary disease progression time, total remission rate, disease control rate, and health-related quality of life The results showed that the study reached the primary end point: compared with the placebo group, the linparza group showed statistically and clinically significant improvement in PFS (median PFS: 7.4 months vs 3.8 months), a 47% reduction in the risk of disease progression or death (HR = 0.53 [95% CI: 0.35-0.82], P = 0.004) The benefits of using lynparza maintenance therapy were consistent across a range of clinically significant endpoints From six months on, at each point in time, the proportion of patients who did not progress was more than twice as high in the lynparza group as in the placebo group (1 year: 34% vs 15%; 2 years: 22% vs 10%) Among the patients with measurable diseases at baseline, 23% responded to lynparza treatment, 12% responded to placebo treatment, and the median course of lynparza treatment was more than 2 years (24.9 months), and the placebo treatment was 3.7 months At the mid-term analysis, the overall survival time (OS) of lynparza treatment group was 18.9 months, and that of placebo group was 18.1 months, with no statistically significant difference (HR = 0.90, P = 0.68) In this study, the safety and tolerability of lynparza were consistent with those in previous studies Polo study is the first positive phase III study to evaluate the efficacy of any PARP inhibitor in the treatment of gbrcam metastatic pancreatic cancer It is a devastating disease with serious unmet medical needs The results from Polo study have brought new hope to patients with little progress in the past 20 years, and further proved the clinical efficacy of lynparza in a variety of BRCA mutation tumor types Lynparza (Lipitor): China was approved in August 2018, marking that ovarian cancer has entered the era of PARP inhibitors Pancreatic cancer is the 12th most common cancer type and the seventh most common cause of cancer death in the world, with the worst survival rate among the most common cancers In each country, the 5-year survival rate after diagnosis is only a single digit (2-9%) The early diagnosis of pancreatic cancer is very difficult Patients usually have no symptoms until the disease develops to the late stage About 80% of patients are diagnosed in the stage of metastasis The average survival time of these patients is less than one year In the past few decades, there has been little progress in the diagnosis and treatment of pancreatic cancer The current treatment is surgery (only applicable to 10-20% of patients), chemotherapy and radiotherapy, highlighting the critical unmet need for more effective treatment options Globally, about 460000 new cases have been confirmed in 2018, and 5-7% of all cases are from gbrcam Lynparza was approved by FDA in December 2014 and became the first PARP inhibitor approved in the world Lynparza is a pioneering and oral PARP inhibitor, which can kill cancer cells preferentially by using the defects of DNA repair pathway This mode of action endows lynparza with the potential to treat a wide range of types of tumors with DNA repair defects PARP is associated with a wide range of tumor types, especially breast and ovarian cancer At present, AstraZeneca is carrying out a number of clinical studies to investigate the potential of lynparza for a wide range of tumor types, including breast cancer, prostate cancer and pancreatic cancer AstraZeneca and MSD reached a global strategic cooperation in oncology in July 2017 to jointly develop and commercialize lynparza and selumetinib, another MEK inhibitor, to treat multiple types of tumors AstraZeneca has high expectations for lynparza and believes that the annual sales of the drug will exceed 2 billion US dollars In the Chinese market, lynparza was approved by China National Drug Administration (CNDA) on August 23, 2018 for the maintenance treatment of platinum sensitive recurrent ovarian cancer This approval makes lynparza the first target drug approved for ovarian cancer treatment in the Chinese market, marking that China's ovarian cancer treatment has entered the era of PARP inhibitors Earlier this month, lynparza was again approved for first-line maintenance therapy in patients with BRCA mutations in advanced ovarian cancer Lynparza has become the first PARP inhibitor approved for the first-line maintenance therapy of ovarian cancer in China, benefiting from China's strong support for pharmaceutical innovation and accelerating the clinical urgent need for new drug approval On November 28, 2019, lynparza was listed in the national health insurance catalog Source: lynparza recommended by FDA advisory committee for 1st line maintenance treatment of germline BRCA mutated metric pancreatic cancer