The US FDA Accepts and Grants Priority Review to Roche’s NDA of Inavolisib for Treating Breast Cancer
Shots:
- The acceptance & priority review (PDUFA: Nov 27, 2024) for the NDA of inavolisib + Ibrance & fulvestrant was based on P-III (INAVO120, n=325) trial of combination's safety & efficacy vs PBO in PIK3CA-m, HR+, HER2-, locally advanced/metastatic breast cancer post recurrence on/within 12mos. of adjuvant endocrine therapy
- The results depicted more than doubled PFS of 15mos. vs 7.3mos. with a 57% reduced risk of disease worsening/death, OS data was immature, favoring a positive trend & its full assessment is underway. These results will support future global regulatory submissions. Further analysis will be highlighted at ASCO'24
- Inavolisib is under a series of P-III (INAVO120, INAVO121, INAVO122) trials for PIK3CA-m locally advanced or metastatic breast cancer in several combinations
Ref: Roche | Image: Roche
Related News:- Roche’s Inavolisib Receives the US FDA’s Breakthrough Therapy Designation for Breast Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
