Lynparza Becomes First PARP Inhibitor Approved in the EU for gBRCAm HER2-Negative Metastatic Breast Cancer
AstraZeneca
Biopharmaceutical Manufacturer
MSD
Pharmaceutical R&D and Manufacturer
European Union
The European Union (German: Europäische Union; French: Union européenne), abbreviated as the EU, is headquartered in Brussels, the capital of Belgium. It evolved from the European Communities and originally had six founding member states: Germany, France, Italy, the Netherlands, Belgium, and Luxembourg. The Union currently has 28 member states and 24 official languages.In December 1991, the European Council meeting in Maastricht adopted the Treaty on European Union, commonly known as the Maastricht Treaty. On November 1, 1993, the Maastricht Treaty officially entered into force, marking the formal establishment of the European Union. In 2012, the EU was awarded the Nobel Peace Prize.Donald Tusk serves as President of the European Council, and Antonio Tajani is President of the European Parliament. Jean-Claude Juncker, former Prime Minister of Luxembourg, is President of the European Commission.The EU’s treaties have been amended multiple times, and its operations are governed by the Treaty of Lisbon. Politically, all member states are democracies (according to The Economist’s 2008 Democracy Index). Economically, it constitutes the world’s second-largest economic entity (with Germany, France, and Italy being members of the G8). Militarily, the vast majority of EU member states are also members of the North Atlantic Treaty Organization (NATO).
AstraZenecaand Merck Sharp & Dohme announced on April 10 that the European Commission had approved Lynparza (olaparib) as monotherapy for patients with germline BRCA1/2 mutations (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastaticBreast CancerFor adult patients, this is also the first PARP inhibitor approved by the European Union for this indication. This approval adds to the drug’s two existing authorized uses in ovarian cancer (advanced disease and maintenance therapy), marking another expansion to a broader global patient population following its similar approval in the United States in 2018.
This marks the third indication approval for Lynparza in the European Union. AstraZeneca and MSD are working together to make Lynparza available to more patients across multiple conditions as soon as possible. The drug currently has an extensive clinical development program, including the ongoing Phase III OlympiA trial, which is evaluating the efficacy of Lynparza as adjuvant therapy in patients with gBRCAm HER2-negative breast cancer.
The newly approved indication expands the use of LYNPARZA for patients who are not suitable candidates for further anthracycline- and taxane-based chemotherapy in the (neo)adjuvant or metastatic setting; as well as for patients with hormone receptor (HR)-positive breast cancer who have experienced disease progression during or after prior endocrine therapy, or who are deemed unsuitable for endocrine therapy.
This approval is based on data from the randomized, open-label Phase III OlympiAD trial, which evaluated the efficacy of LYNPARZA versus physician’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial, Lynparza demonstrated a median progression-free survival (PFS) improvement of 2.8 months (7.0 months vs. 4.2 months); the objective response rate (ORR) was 52%, twice that of the chemotherapy group (23%). The percentage of patients who discontinued treatment was 5% in the Lynparza group and 8% in the chemotherapy group.
These data demonstrate a significant step forward in breast cancer treatment, but they remain insufficient; without overall survival data, the therapy may face resistance from health technology assessment (HTA) bodies such as the UK’s National Institute for Health and Care Excellence (NICE).
Lynparza is AstraZeneca’s revival of itsTumorAs a core asset of its business and the cornerstone of its strategic alliance with Merck Sharp & Dohme (MSD), the two companies jointly market this drug. The new approval will help Lynparza maintain its market growth and its leadership position in the field of PARP inhibitors. According to EvaluatePharma forecasts, Lynparza’s annual revenue is projected to reach $2.2 billion by 2024.
In 2018, an estimated 2.1 million new cases of breast cancer were reported globally,DiagnosisApproximately 30% of women with early-stage breast cancer will progress to advanced-stage disease. Among all breast cancer cases,HeredityRisk factors account for approximately 25%, while mutations in the BRCA1, BRCA2, CHEK2, TP53, and PTEN genes constitute approximately 5%-10% of all breast and ovarian cancer cases. Patients with BRCA1/2 mutations can benefit from Lynparza; AstraZeneca and MSD are currently collaborating with healthcare systems to ensure routine adoption.DiagnosisTests to identify patients.
AstraZenecaTumorDave Fredrickson, Executive Vice President of AstraZeneca, stated, “With this approval, Lynparza will provide a targeted, oral, chemotherapy-free treatment option for breast cancer patients across the European Union. This therapy underscores the importance of biomarker testing, including BRCA gene mutations, hormone receptor status, and HER2 expression, which can help physicians make the most informed treatment decisions for their patients.”
“Lynparza demonstrated a significant improvement in progression-free survival compared with chemotherapy in patients with metastatic breast cancer and germline BRCA mutations in the OlympiAD trial, which supported this approval,” said Dr. Roy Baynes, Chief Medical Officer of Merck Research Laboratories, Head of Global Clinical Development, and Senior Vice President. “We look forward to launching this new therapy across the European Union, with the hope that it will improve outcomes for many patients.”
AstraZeneca and MSD have undoubtedly achieved successive victories in their collaboration on Lynparza, recently releasing promising results for Lynparza in prostate cancer and particularly refractory pancreatic cancer. The two partners also recently announced a collaboration withDiagnosisfurther collaboration with Myriad, a specialized company in this field. Myriad’s BRACAnalysis CDx will be used to identify germline BRCA mutations in male patients with metastatic castration-resistant prostate cancer (mCRPC) and in patients enrolled in the Phase 3 PROfound study.BioValleyBioon.com）