The FDA’s approval of inavolisib breast cancer treatment in combination with palbociclib and fulvestrant is significant. It provides a new treatment option for a challenging patient population. This treatment is specifically for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. Patients eligible for this approval have experienced recurrence after completing adjuvant endocrine therapy.
The FoundationOne Liquid CDx assay was approved as a companion diagnostic device. This device helps identify which breast cancer patients are eligible for the inavolisib treatment regimen.
– The primary efficacy outcome was assessed for progression-free survival (PFS) by investigators per RECIST version 1.1.
– The median PFS was 15.0 months (95% CI: 11.3, 20.5) for the inavolisib + palbociclib + fulvestrant arm, compared to 7.3 months (95% CI: 5.6, 9.3) for the placebo + palbociclib + fulvestrant arm (Hazard ratio 0.43 [95% CI: 0.32, 0.59], p-value < 0.0001).
Although the interim analysis of overall survival did not achieve statistical significance, it suggested a trend in favor of the inavolisib regimen.
This approval took place under Project Orbis, which is part of the FDA Oncology Center of Excellence. It involves collaboration with various international regulatory agencies, including the Australian Therapeutic Goods Administration (TGA), Health Canada, and Switzerland’s Swissmedic.
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Look into the details of this transformative partnership and its implications for the future of healthcare in the region!
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🚨 Are we doing enough to tackle the imminent breast cancer crisis in Africa?
A recent WHO report reveals alarming trends, predicting that 135,000 women could succumb to breast cancer by 2040 unless urgent actions are taken. The report highlights critical gaps in healthcare infrastructure and capacity, emphasizing the need for investment in screening programs and professional training to improve outcomes across the continent.
Review the full article to explore the necessary steps towards reinforcing breast cancer control measures in Africa.
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