European Commission Approves Inavolisib for Advanced Breast Cancer Treatment

On July 22, 2025, the European Commission granted approval for the combination therapy of inavolisib (Itovebi), palbociclib (Ibrance), and fulvestrant (Faslodex) to treat patients suffering from PIK3CA-mutated, estrogen receptor (ER)-positive, HER2-negative advanced breast cancer. This decision marks a significant advancement in treatment options for patients who have experienced disease recurrence within 12 months of completing adjuvant endocrine therapy.

The pivotal INAVO120 clinical trial, which supported the approval, demonstrated substantial improvements in patient outcomes. According to results presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, patients receiving the inavolisib-based regimen exhibited a median progression-free survival (PFS) of 17.2 months, compared to just 7.3 months for those treated with palbociclib and fulvestrant alone (Turner et al., 2025). In addition, the overall survival (OS) for the inavolisib group was significantly higher at 34.0 months versus 27.0 months for the control group, highlighting the therapy's potential to extend life for this patient population.

Dr. Levi Garraway, Chief Medical Officer at Roche, the pharmaceutical company behind inavolisib, emphasized the drug's innovative role in addressing an unmet medical need. He stated, "[Inavolisib] is the first treatment of its kind to improve survival outcomes for those living with PIK3CA-mutated, ER-positive advanced breast cancer."

The INAVO120 trial was a randomized, double-blind, placebo-controlled study that enrolled 325 patients across various regions, including North America, Western Europe, and Asia. Participants were required to have measurable disease and experience disease progression during or within 12 months of completing adjuvant endocrine therapy. The trial's design ensured a robust assessment of both efficacy and safety, leading to the conclusion that the inavolisib regimen was well-tolerated with no new safety signals reported.

The results from the INAVO120 trial have profound implications not only for clinical practice but also for the broader landscape of breast cancer treatment. The combination therapy offers a new hope for a demographic of patients who have limited options following the failure of standard endocrine therapies. As highlighted by Dr. Turner, the principal investigator of the INAVO120 trial, the PFS benefit was consistently observed across all prespecified subgroups, indicating the regimen's broad applicability.

This approval follows a previous endorsement from the U.S. Food and Drug Administration (FDA) in October 2024, further underscoring the therapy's potential in the global effort to improve outcomes for patients with advanced breast cancer. The FDA's endorsement was based on similar data from the INAVO120 trial, affirming the treatment's efficacy in patients identified as having endocrine-resistant, PIK3CA-mutated, hormone receptor-positive disease.

The economic implications of this new therapy are noteworthy, as Roche has indicated that inavolisib could reduce healthcare costs associated with advanced cancer care by potentially delaying the need for more aggressive treatments, including chemotherapy. Further studies will be necessary to evaluate the long-term benefits of this new regimen in real-world settings.

The approval of inavolisib, palbociclib, and fulvestrant signifies a pivotal moment in the fight against advanced breast cancer, offering renewed hope for patients navigating this challenging diagnosis. Continuous monitoring of patient outcomes and further research will be essential to maximize the benefits of this promising combination therapy in the years to come.