Core Opinion - Roche's Itovebi therapy for breast cancer has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), with a final decision from the European Commission expected soon [1] Group 1: Treatment Details - The company is seeking approval for a combination regimen of Itovebi with Pfizer's Ibrance and AstraZeneca's Faslodex, targeting adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer [2] - Itovebi, in combination with Ibrance and Faslodex, is already approved in several regions, including the United States, with additional applications under review globally [3] Group 2: Clinical Study Results - The favorable CHMP opinion is based on Roche's phase III INAVO120 study, which showed a 57% reduction in the risk of disease progression or death for patients receiving the Itovebi-based regimen compared to those treated with Ibrance and Faslodex alone [4] - The regimen was well tolerated, with no new safety concerns identified [6] Group 3: Future Prospects - Positive top-line results from the final overall survival analysis of the INAVO120 study confirmed a statistically significant survival advantage with the Itovebi-based treatment, with full results expected to be presented at the 2025 American Society of Clinical Oncology Annual Meeting [7] - Roche is evaluating various other combinations of Itovebi in three late-stage studies for treating PIK3CA-mutated breast cancer and plans further clinical investigations to extend the therapy's benefits [9] Group 4: Market Context - Year to date, Roche's shares have increased by 13.7%, contrasting with a 5.7% decline in the industry [3]
Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer