Lynparza Combo Recommended by EU Committee as First-line Maintenance for Advanced Ovarian Cancer

Lynparza Combo Recommended by EU Committee as First-line Maintenance for Advanced Ovarian Cancer
Lynparza (olaparib), in combination with bevacizumab, has been recommended for approval in the European Union (EU) as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. The positive opinion released by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, also includes patients who have advanced fallopian tube or primary peritoneal cancer. CHMP’s recommendations are generally accepted by the European Commission, which makes the final decision on approval. HRD-positive tumors included in the recommendation are those that carry mutations in the BRCA genes, involved in DNA repair, and/or exhibit genomic instability (a high frequency of mutations within the genome). Since these tumors rely on DNA repair mechanisms involving mainly the PARP enzyme — a DNA damage sensor — they are more likely to respond to therapies blocking PARP activity, named PARP inhibitors. These include Lynparza, an oral treatment developed by AstraZeneca and Merck (known as MSD outside North America). “HRD is an important biomarker of advanced ovarian cancer that can inform how physicians in the EU treat this aggressive type of cancer,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a press release. José Baselga, MD, PhD, executive vice president of AstraZeneca’s oncology research and development, said that “this recommendation is a vital step toward addressing a large and critical unmet need and could bring a new treatment option that significantly delays relapse in this difficult-to-treat di
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