June 03, 2020 /
BioValleyBIOON/ ---
AstraZeneca(AstraZeneca) and Merck & Co. recently jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of the targeted anticancer drug Lynparza (Chinese brand name: Lipzhuo; generic name: olaparib, olaparib tablets) for first-line maintenance treatment in patients with metastatic pancreatic cancer carrying germline BRCA mutations (gBRCAm). Specifically, this applies to adult patients with metastatic pancreatic cancer harboring germline BRCA1/2 mutations whose disease has not progressed after receiving at least 16 weeks of platinum-based chemotherapy as part of a first-line regimen.
The CHMP opinion will now be submitted to the European Commission (EC) for review, which is expected to make a final decision within the next two months. In the United States, Lynparza was approved in December 2019.
FDAApproved for first-line maintenance treatment of adult patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. Lynparza is the only PARP inhibitor approved for the treatment of gBRCAm metastatic pancreatic cancer. In addition to the United States, Lynparza has also been approved in several other countries, with regulatory reviews ongoing in the European Union and other jurisdictions.
This May, Lynparza also received U.S.
FDAApproval: (1) For the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair gene mutations (HRRm); (2) In combination with bevacizumab, for first-line maintenance treatment in adult patients with homologous recombination deficiency (HRD)-positive advanced ovarian cancer.
Lynparza is the first PARP inhibitor launched globally, indicated for the treatment of four types of cancer, including: ovarian cancer,
Breast Cancer, pancreatic cancer, and prostate cancer. This drug is a first-in-class, oral poly(ADP-ribose) polymerase (PARP) inhibitor that has been approved for seven therapeutic indications, four of which are for ovarian cancer, including two for first-line maintenance treatment of ovarian cancer. The specific indications are: (1) first-line maintenance treatment of adult patients with BRCA-mutated (BRCAm) advanced ovarian cancer; (2) combination with bevacizumab for first-line maintenance treatment of adult patients with homologous recombination deficiency (HRD)-positive advanced ovarian cancer; (3) maintenance treatment of adult patients with recurrent ovarian cancer; (4) treatment of adult patients with germline BRCA-mutated (gBRCAm) advanced ovarian cancer; (5) treatment of adult patients 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 homologous recombination repair mutation (HRRm), metastatic castration-resistant prostate cancer (mCRPC) who have progressed after novel hormonal therapy.
The CHMP’s positive opinion 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 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.
Notably, Lynparza is in Phase III
Clinical TrialsThe only PARP inhibitor proven to benefit patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer in the first-line maintenance setting.
AstraZeneca
TumorJosé Baselga, Executive Vice President of Research and Development, stated: “Over the past few decades, therapeutic progress for patients with advanced pancreatic cancer has been limited. We are now one step closer to bringing the first targeted therapy to certain biomarker-selected patients with advanced pancreatic cancer in the European Union.”
Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at MSD Research Laboratories, stated: “Pancreatic cancer is a devastating disease, and we are committed to changing patient outcomes. Data from the Phase III POLO study demonstrate that treatment with Lynparza prolonged progression-free survival in certain patients with advanced pancreatic cancer. We hope to bring this therapy to patients in the European Union soon.”
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 death worldwide, exhibiting the poorest survival rate among the most common cancers. In every country, the 5-year survival rate after diagnosis is only in the single digits (2–9%). 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.
Diagnosis, the average survival time for these patients is less than one year.
Pancreatic Cancer Over the Past Few Decades
DiagnosisThere 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 (Olaparib): Already launched in China and included in the National Reimbursement Drug List.
Lynparza was approved in the United States in December 2014
FDAApproved for marketing, it became the first PARP inhibitor approved globally. Lynparza is a first-in-class, oral PARP inhibitor that preferentially 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 broad spectrum of tumor types, particularly breast and ovarian cancers. Currently, AstraZeneca is conducting multiple clinical studies to investigate the use of Lynparza across a wide variety of
Tumorpotential, including breast cancer, prostate cancer, and pancreatic cancer.
AstraZeneca and MSD entered into a global strategic collaboration in oncology in July 2017 to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, for the treatment of multiple types
Tumor. AstraZeneca has high expectations for Lynparza, believing that the drug's annual sales will exceed $2 billion.
In the Chinese market, Lynparza (Lipuzhuo) was approved by the China National Drug 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 the treatment of 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 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 recommended for
approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer
