Madrid-Teh Spanish Ministry of Health has authorized public funding for the targeted therapy alectinib (Alecensa) beginning December 1, 2025, offering new hope for patients wiht early-stage ALK-positive non-small cell lung cancer. The decision follows data from the Phase III Alina trial demonstrating a significant 76% reduction in the risk of cancer recurrence or death post-surgery [[1]]. This funding aims to improve access to the medication, wich is especially impactful given that ALK+ lung cancer disproportionately affects younger individuals and is often unrelated to smoking [[2]].
Madrid, Spain – The Spanish Ministry of Health has approved funding for alectinib (Alecensa), a medication developed by Roche, to prevent cancer recurrence following surgery for early-stage ALK-positive non-small cell lung cancer. This decision, effective December 1, 2025, is based on promising results from the Phase III Alina trial, which demonstrated a 76% reduction in the risk of the cancer returning or of death in patients with this specific type of lung cancer.
Lung cancer with the ALK+ mutation tends to affect a younger demographic, with a median age of 52, and is more common in women, accounting for 54% of cases. Importantly, this subtype is not typically linked to smoking history. Early detection and targeted therapies are crucial in improving outcomes for lung cancer patients, and this funding represents a significant step forward in providing access to such treatment.
Alectinib Adjuvant Therapy Reduces Recurrence Risk by 76% in ALK+ Lung Cancer Patients
According to Dr. Mariluz Amador, Medical Director of Roche Farma España, the use of alectinib “is going to change the paradigm of patient treatment, providing greater comfort, saving time and easing the burden on healthcare assistance.” The oral medication is prescribed for a two-year period, and has shown continued safety and benefit for patients with advanced disease for longer than two years, leading to improved prognoses.
Currently, some patients in certain Spanish regions are already receiving alectinib as adjuvant therapy following surgery. However, Dr. Fernando López-Ríos, Head of the Pathology Section at Hospital 12 de Octubre in Madrid, emphasized the importance of streamlining diagnostic processes. “The laboratory circuits are complex, but workflows cannot continue if they do not have a sufficient number of patients and samples to analyze. Including patients in these workflows will speed up results and make them more cost-effective,” he said. Faster and more efficient diagnostics are essential to ensure all eligible patients can benefit from this treatment.
Alectinib Side Effects
Dr. Javier de Castro, Head of the Medical Oncology Section at Hospital La Paz in Madrid, explained that any side effects associated with alectinib are “deliberately caused by blocking the specific protein.” These side effects are generally mild and manageable, such as gastrointestinal issues, and are typically well-tolerated by patients.
A key component of successful treatment with alectinib is identifying patients who will respond best to the drug. This requires detecting the ALK+ biomarker in patients diagnosed with non-small cell lung cancer (NSCLC), both in early and advanced stages. “Molecular diagnosis is essential to identify the genomic alterations of each tumor, which allows for the selection of more effective targeted therapies,” explained Dr. López-Ríos. “Having this information in the early stages is essential.”
