Roche's Genentech Granted Priority Review By FDA For Inavolisib, An Investigational Oral Therapy, In Combination With Palbociclib (Ibrance) And Fulvestrant

Benzinga · May 29 01:08

– Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options –
– Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting –
– The target action date for the FDA decision is November 27, 2024 –
The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

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Roche's Genentech Granted Priority Review By FDA For Inavolisib, An Investigational Oral Therapy, In Combination With Palbociclib (Ibrance) And Fulvestrant

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