Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation
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- The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial
- P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n= 325) and showed a 57% reduction in disease worsening or death vs palbociclib & fulvestrant alone as 1L treatment; the trial met its 1EP (PFS) & 2EPs (ORR & CBR) with OS follow-up continuing for the next analysis
- Results from INAVO120 are also being used for submissions to other global health authorities. Additionally, the company is evaluating Itovebi in two more P-III trials (INAVO121 & INAVO122) for the same indication
Ref: Roche | Image: Roche
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