AZ/Merca East Lynparza EU approval is on the fly

AstraZeneca and Merck and Co have jointly announced that the European Medicines Agency's (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of the targeted cancer drug Lynparza (Chinese Brand Name: Liptro, General Name: Ola Olapali tablets) for first-line maintenance therapy in patients with metastatic pancreatic cancer with BRCA mutation (gBRCAm) in the reproductive system, specifically in adult patients with metastatic pancreatic cancer who did not progress after receiving platinum-containing chemotherapy for at least 16 weeks in a first-line chemotherapy programme.CHMP's comments will now go to the European Commission, which is expected to make a final review decision within the next two months. In the United States, Lynparza was approved by the FDA in December 2019 for first-line maintenance treatment of adult patients with gBRCAm metastatic pancreatic cancer. Lynparza is the only PARP inhibitor approved for the treatment of gBRCAm metastatic pancreatic cancer, and in addition to the United States, Lynparza has been approved in several other countries and regulatory reviews are under way in the European Union and other jurisdictions.In May, Lynparza also received FDA approval: (1) for the treatment of metastatic degenerative resistance prostate cancer (mCRPC) patients with HRRm;Lynparza is the world's first PARP inhibitor to be used to treat four types of cancer, including ovarian, breast, pancreatic and prostate cancers. The drug is a pioneering, oral poly-polymerase (PARP) inhibitor, has been approved for 7 therapeutic adaptations, of which 4 are ovarian cancer, 2 are first-line maintenance treatment of ovarian cancer. Specifically: (1) first-line maintenance treatment of adult patients with BRCAm advanced ovarian cancer; (2) combined beval single-anti-first-line maintenance treatment of HRD-positive adult patients with advanced ovarian cancer; (3) maintenance treatment of adult patients with relapsed ovarian cancer; (4) advanced gBRCAm ovarian cancer Adult patients; (5) adult patients treated with gBRCAm, HER2 negative (HER2-) metastatic breast cancer; (6) first-line maintenance treatment of adult patients with gBRCAm metastatic pancreatic cancer; (7) treatment of patients with HRRm and mCRPC who progressed after receiving new hormone therapy.CHMP's positive review is based on the results of the Phase III POLO trial. The data have been published in the New England Journal of Medicine (NEJM). The trial showed that Lynparza, a first-line maintenance therapy, nearly doubled the progression-free survival of gBRCAm metastatic pancreatic cancer patients (medium PFS: 7.4 months vs. 3.8 months) and significantly reduced the risk of disease progression or death by 47 percent compared to placebo. In this trial, Lynparza's safety and tolerance were consistent with previous trials.It is worth mentioning that Lynparza is the only PARP inhibitor that has been shown to be beneficial to patients in the treatment of gBRCAm metastatic pancreatic cancer in Phase III clinical trials."Over the past few decades, there has been limited progress in the treatment of patients with advanced pancreatic cancer," said Jose Baselga, Executive Vice President of Cancer Research and Development at AstraZeneatic. We are now one step closer to applying the first targeted drug to patients with advanced pancreatic cancer in the European Union selected by certain biomarkers.is a devastating disease and we are committed to changing patient prognostication," said Roy Baynes, Chief Medical Officer, Senior Vice President and Global Clinical Development Director, Mercado Research Laboratory, . Data from the Phase III POLO study show that in some patients with advanced pancreatic cancer, Lynparza treatment prolongs the disease's progress-free survival. We hope to bring this treatment to patients in the European Union soon. Pancreaticis a deadly cancer with very high unseeded medical needs. Pancreatic cancer is the 11th most common type of cancer and the seventh leading cause of cancer death in the world, with the worst survival rate among the most common cancers, with a single-digit (2-9%) five-year survival rate in each country. Early diagnosis of pancreatic cancer is difficult, and patients are usually asymptomatic until the disease develops to a late stage, with about 80 percent of patients diagnosed during the metastatic phase, with an average survival time of less than a year.There has been little progress in the diagnosis and treatment of pancreatic cancer over the past few decades, and current treatments, mainly surgery (only for 10-20% of patients), chemotherapy and radiotherapy, have highlighted the critical unsealed need for more effective treatment options. Globally, about 460,000 new cases were confirmed in 2018, with gBRCAm pancreatic cancer accounting for 5-7% of all cases.Lynparza: Listed in China and listed in the National Health Insurance Directory Lynparza was approved by the FDA in December 2014 to become the world's first approved PARP inhibitor. Lynparza is a pioneering, oral PARP inhibitor that prioritizes the killing of cancer cells with defects in DNA repair pathways, a pattern that gives Lynparza 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. AstraZenecom is currently conducting clinical studies to investigate Lynparza's potential for a wide range of types of tumours, including breast, prostate and pancreatic.AstraZeneza and Mercedon reached a global strategic partnership on oncology in July 2017 to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, to treat a wide range of tumors. AstraZeneta has high expectations for Lynparza, which expects annual sales of the drug to exceed $2 billion.In the Chinese market, Lynparza was approved by China's State Drug Administration (CNDA) on August 23, 2018 for the maintenance of platinum-sensitive relapsed ovarian cancer. The approval makes Lynparza the first targeted drug approved for ovarian cancer treatment in the Chinese market, marking the beginning of the ERA of ovarian cancer treatment in China.
In early December 2019, Lynparza was approved again for first-line maintenance treatment in patients with BRCA mutated advanced ovarian cancer. Benefiting from China's strong support for pharmaceutical innovation and accelerated clinical approval of new drugs, Lynparza became the first PARP inhibitor approved in China for first-line maintenance therapy for ovarian cancer. On November 28, 2019, Lynparza was added to the National Health Insurance List. (
Bio Valley
)