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AstraZeneca and Merck’s LYNPARZA® (olaparib) Approved in Japan as First-Line Maintenance Therapy in Patients with BRCA-Mutated Advanced Ovarian Cancer

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Advances in understanding the role of BRCA mutations and PARP inhibition have fundamentally changed how physicians can treat this aggressive type of cancer. In Japan, an estimated 10,672 new cases were expected to be diagnosed in 2018, with approximately 5,215 deaths. For all types of ovarian cancer, the five-year relative survival is approximately 47%. For newly-diagnosed advanced ovarian cancer, the primary aim of treatment is to delay progression of the disease for as long as possible. Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

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