Roche Announces That The FDA Granted Breakthrough Therapy Designation To Genentech's Inavolisib For Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With PIK3CA Mutation
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Roche announced that the FDA granted Breakthrough Therapy Designation to Genentech's Inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation. The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone.
May 21, 2024 | 5:32 am
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Roche's Genentech received FDA Breakthrough Therapy Designation for Inavolisib, showing promising Phase III results in advanced HR-positive, HER2-negative breast cancer with PIK3CA mutation.
The FDA Breakthrough Therapy Designation is a significant regulatory milestone that often leads to accelerated approval processes. The positive Phase III results further enhance the potential for Inavolisib to be a successful treatment, likely boosting investor confidence and stock price in the short term.
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