Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. These patients have experienced recurrence on or after completing adjuvant endocrine therapy and have been detected with the condition through an FDA-approved test.
The approval comes on the heels of the successful INAVO120 study, a Phase III trial that demonstrated the efficacy and safety of the Itovebi combination therapy. The study involved 325 patients who had disease progression during or within 12 months of completing adjuvant endocrine therapy and had not received prior systemic therapy for locally advanced or metastatic disease. The results were compelling, with the Itovebi combination therapy group showing a significant improvement in progression-free survival (PFS) of 15.0 months compared to 7.3 months, and an overall response rate (ORR) of 58% compared to 25%.
Additionally, the FDA has approved the FoundationOne Liquid CDx assay as a companion diagnostic device, which will help identify patients with breast cancer who are eligible for treatment with the Itovebi combination regimen. This move is set to enhance personalized medicine in oncology, bringing a new dimension to the treatment of breast cancer.- Flcube.com
