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Lynparza Receives Positive CHMP Opinion for First-Line Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer in the EU

Apr 30, 2019 09:41 CST Updated 09:41
AstraZeneca

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Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


April 30, 2019/BIOON/--UK pharmaceutical giantAstraZeneca(AstraZeneca) and its partner Merck & Co. recently jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Lynparza (Chinese brand name: Lizhuo; generic name: olaparib, olaparib tablets) as a first-line maintenance therapy for patients with BRCA-mutated (BRCAm) advanced ovarian cancer who are in complete or partial response after first-line platinum-based chemotherapy, specifically: patients with advanced (FIGO stage III and IV) epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer carrying BRCA1/2 mutations.

It is worth noting that Lynparza is the only PARP inhibitor that significantly prolongs progression-free survival (PFS) as a first-line maintenance therapy for this patient population. The CHMP’s opinion will now be submitted to the European Commission (EC), which will consider the CHMP’s opinion and issue a final review decision within the next 2–3 months. In the United States, Lynparza was approved in December 2018FDAApproved for the above indications, becoming the first PARP inhibitor as first-line maintenance therapy for advanced ovarian cancer with BRCA mutations.

The CHMP’s recommendation to approve Lynparza is based on the results of the pivotal Phase III clinical trial SOLO-1. The study results demonstrated that, compared with placebo, Lynparza achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 70% (HR=0.30 [95% CI=0.23–0.41], p<0.001). After a median follow-up of 41 months, the median PFS had not been reached in the Lynparza treatment group, whereas it was 13.8 months in the placebo group. In the Lynparza treatment group, 60.4% of patients remained free of disease progression within 36 months of treatment, compared with 26.9% in the placebo group. In this study, the safety profile of Lynparza was consistent with that observed in previous studies.

AstraZenecaTumorDave Fredrickson, Head of the Business Unit and Executive Vice President, stated, “Given that 70% of ovarian cancer patients worldwide relapse within the first three years after initial treatment, there remains a significant unmet need in the treatment of advanced ovarian cancer. The results from the SOLO-1 study confirm the potential of using Lynparza early in the treatment pathway as maintenance therapy and underscore the importance of determining BRCA mutation status as soon as possible upon diagnosis.”

Roy Baynes, Head of Global Clinical Development, Senior Vice President, and Chief Medical Officer of Merck Research Laboratories, stated, “Women with advanced ovarian cancer need and deserve new treatment options. In the SOLO-1 study, Lynparza demonstrated a significant progression-free survival benefit as maintenance therapy in patients with advanced BRCA-mutated ovarian cancer who responded to first-line platinum-based chemotherapy. If approved, this expanded indication could change the treatment paradigm for patients with BRCA-mutated advanced ovarian cancer in Europe.”

Currently, AstraZeneca and Merck Sharp & Dohme are advancing late-stageBreast Cancerother clinical studies, including the ongoing GINECO/ENGOTov25 Phase III PAOLA-1 study. This study is evaluating Lynparza in combination with Roche’s Avastin (generic name: bevacizumab) as maintenance therapy for patients with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. The results are expected to be announced in the second half of 2019.

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 endows Lynparza with the potential to treat a wide range of tumors harboring DNA repair deficiencies. PARP is associated with a broad spectrum ofTumorType-related, especially breast cancer and ovarian cancer.

Lynparza is the first PARP inhibitor launched globally, initially approved in the United States in December 2014.FDAApproved for patients with advanced ovarian cancer harboring deleterious or suspected deleterious germline BRCA mutations (gBRCAm). To date, the drug has also been approved in more than 60 countries worldwide for platinum-sensitive recurrent ovarian cancer, regardless of BRCA status. Furthermore, it has been approved in the United States, Canada, Japan, and Australia for germline BRCA-mutated, HER2-negative metastatic breast cancer in patients who have previously received chemotherapy; in the European Union, this indication includes patients with locally advanced breast cancer.

AstraZeneca and MSD entered into a global strategic oncology collaboration in July 2017 to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, for the treatment of various types of tumors. Currently, both parties are conducting multiple clinical studies to investigate the use of Lynparza across a broad range ofTumorpotential, including breast cancer, prostate cancer, and pancreatic cancer.

In the Chinese market, Lynparza (olaparib) 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. (Bioon.com)