Roche’s Inavolisib Receives the US FDA’s Breakthrough Therapy Designation for Breast Cancer
Shots:
- The US FDA has granted BTD to inavolisib + Ibrance & fulvestrant based on the P-III (INAVO120) study assessing its safety & efficacy vs PBO for treating PIK3CA-mutated, HR+, HER2-ve, locally advanced/metastatic breast cancer patients (n=325). Results have also been submitted to the EMA and other global health authorities
- The data demonstrated 57% PFS with inavolisib-based regimen vs palbociclib & fulvestrant alone (15.0mos. vs 7.3mos.) and an immature OS, although it favoured a positive trend. Follow-up for OS continues
- The company is currently assessing inavolisib in several combinations under a series of P-III (INAVO120, INAVO121, INAVO122) trials for treating PIK3CA-mutated locally advanced or metastatic breast cancer
Ref: Roche | Image: Roche
Related News:- Genentech Reports the Results of Inavolisib Combination Therapy in P-III Trial for the Treatment of 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.
