A new drug to treat breast cancer will be available in Spanish public hospitals. The Ministry of Health has approved funding for inavolisib, a drug that has proven effective in treating advanced-stage breast cancers with a mutation in the PIK3CA gene.
This mutation is common in patients who have experienced an early relapse after initial treatment and who are resistant to hormone therapy. Therefore, treatment with inavolisib is particularly useful in cases with a poorer prognosis, where three factors are present: metastasis, resistance to endocrine therapy, and a mutation in the PIK3CA gene.
The mutation is also one of the most common in luminal breast cancer, which accounts for about 70% of all breast cancer cases. In patients with this mutation, inavolisib has been associated with a 33% reduction in the risk of death and has delayed the need to start chemotherapy by two years.
A project in which public hospitals participated
Numerous public hospitals in Madrid have participated in clinical trials of the new drug, including the 12 de Octubre University Hospital and the Gregorio Marañón University General Hospital. Finally, starting this July 2026, breast cancer treatment with inavolisib (marketed by Roche under the name Itovebi) will be covered by the Spanish public health system. Approval and funding by the Ministry of Health came one year after the European Commission gave its green light to the treatment.
Molecular diagnosis is key to prescribing inavolisib specifically to patients who need it; that is, when a breast cancer tumor relapses, a test must be performed to identify the PIK3CA gene mutation. This test has already been included in the National Health System’s standard catalog of genetic tests.