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FDA grants Priority Review to Roche s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

Priority Review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options1,2Additional analyses of INAVO120 will be presented in an.

FDA grants Priority Review to Roche s inavolisib for

FDA grants Breakthrough Therapy Designation to Roche s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the.

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