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Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

Off-the-shelf cell therapies hold immense promise for revolutionizing precision medicine by offering accessible and affordable treatments. However, overcoming the immune system's rejection and navigating the FDA's approval process are crucial challenges.

The U.S. healthcare system has undergone significant changes, particularly in the pharmaceutical industry, due to factors like telemedicine, integrated delivery networks, and value-based care. This has challenged traditional sales models and increased the need for more strategic engagement with clinical executives.