RAHWAY, N.J. - AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
The CHMP based its positive opinion on results from the Phase 3 OlympiA trial presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine in June 2021.
Breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020. In the European Union (EU), one in seven people who were assigned female at birth will develop breast cancer in their lifetime. Approximately 75% of breast cancer patients worldwide are diagnosed with early breast cancer; however, a quarter of these patients will experience disease recurrence following surgery. In Europe, germline BRCA mutations are found in approximately 9% of patients.
Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King's College London, said: 'For patients with high-risk, early-stage breast cancer, the risk of recurrence remains unacceptably high, and cancer will return for more than one in four of these patients. Today's recommendation is hopeful news for patients in Europe, as we move closer to setting a potential new standard of care that improves overall survival in patients suitable for treatment with olaparib.'
Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, 'If approved, LYNPARZAwill provide a new targeted treatment option for patients with germline BRCA-mutated, HER2-negative early breast cancer in Europe. By treating patients as early as possible in their disease, we hope to avoid life-threatening recurrence and give people more time with their loved ones.'
Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, 'Patients with germline BRCA-mutated, HER2-negative early breast cancer will often develop breast cancer at an earlier age than those without BRCA mutations, impacting people in their prime. Today's positive opinion brings us closer to our goal of offering a much-needed new treatment option to these patients in Europe.'
In the trial, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p
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