Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer

Roche RHHBY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Itovebi (inavolisib) therapy for breast cancer. A final decision from the European Commission is expected soon.The company is seeking approval for a combination regimen of Itovebi with Pfizer’s PFE Ibrance (palbociclib) and AstraZeneca’s AZN Faslodex (fulvestrant). The intended treatment population includes adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. PFE’s Ibrance and AZN’s Faslodex are both currently approved for breast cancer treatment.Please note that Roche’s Itovebi, in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex, is currently approved for the same indication as above in several geographies, including the United States, with additional applications under review by other regulatory authorities worldwide.Year to date, shares of RHHBY have surged 13.7% against the industry’s decline of 5.7%.Image Source: Zacks Investment ResearchMore on the Positive CHMP Opinion for RHHBY’s Itovebi TherapyThe favorable CHMP opinion is supported by findings from Roche’s phase III INAVO120 study, which demonstrated a 57% reduction in the risk of disease progression or death (progression-free survival) for patients receiving the Itovebi-based regimen compared with those treated with Pfizer’s Ibrance and AstraZeneca’s Faslodex alone in the first-line setting. This benefit was consistent across all pre-specified subgroups, including patients with more aggressive disease that had spread to three or more locations. Additionally, the regimen was well tolerated, with no new safety concerns identified.In January 2025, positive top-line results from the final overall survival (OS) analysis of the INAVO120 study were announced, confirming a statistically significant and clinically meaningful survival advantage with the Itovebi-based treatment. Although OS data were still maturing at the time of the primary analysis, a clear favorable trend had already emerged. Full OS results are expected to be presented during an oral session at the 2025 American Society of Clinical Oncology Annual Meeting.Per Roche, PIK3CA mutations, which occur in roughly 40% of HR-positive breast cancers, are associated with more aggressive disease and poorer survival outcomes. This highlights the critical need for early PIK3CA mutation testing before initiating first-line treatment, enabling timely access to effective PI3K-targeted therapies for patients with a less favorable prognosis. The Itovebi-based regimen could redefine the standard of care in this first-line setting, where current treatment options remain limited, pending approval.Apart from the INAVO120 study, Roche is simultaneously evaluating various other combinations of Itovebi in three late-stage studies for treating PIK3CA-mutated, locally advanced or metastatic breast cancer. RHHBY is also planning further clinical investigations in breast cancer and other tumor types, aiming to extend the potential benefits of this targeted therapy to a broader population of patients with PIK3CA mutations.Roche Holding AG Price and Consensus Roche Holding AG price-consensus-chart | Roche Holding AG QuoteRHHBY’s Zacks Rank & Stock to ConsiderRoche currently carries a Zacks Rank #3 (Hold).A better-ranked stock in the biotech sector is Bayer BAYRY, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 43.4%. BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 7 Best Stocks for the Next 30 DaysJust released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks