FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
View original at finance.yahoo.comFDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer – Filing acceptance based on Phase III data showing giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus sta…
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Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type
80% confidenceThis acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population
80% confidenceGlobally, 2.3 million women are diagnosed with breast cancer and 670,000 die from the disease every year
80% confidenceIn the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations
80% confidenceThe clinically meaningful benefit seen with giredestrant could enable an important new treatment option to help delay disease progression or death in people with advanced, ER-positive breast cancer
80% confidenceER-positive breast cancer accounts for approximately 70% of breast cancer cases
80% confidenceThe persevERA readout in first-line ER-positive breast cancer is expected in the first half of this year
80% confidenceGiredestrant plus everolimus could be the first and only oral SERD combination approved in the post-CDK4/6 inhibitor setting
80% confidence