Roche announces that the U.S. FDA has granted Breakthrough Therapy Designation - the 29th in its oncology portfolio - to its inavolisib for hormone receptor-positive, HER2-negative advanced breast cancer with a PIK3CA mutation.

This designation is based on the results of phase III INAVO120, showing that the involisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in first-line treatment.

Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation, and often face a poorer prognosis and resistance to endocrine therapy", stresses the Swiss healthcare group.

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