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Jul 14, 2025, 18:25

Therapeutic Update: Nimotuzumab and Vinorelbine for Midline Gliomas – AIEOP

AIEOP – The Italian Association of Pediatric Hematology and Oncology shared a post on LinkedIn:

“Therapeutic Update: Nimotuzumab and Vinorelbine for Midline Gliomas!!️

On 20 June 2025, the AIFA approved, in the context of drugs not in current use, the combination of Nimotuzumab and Vinorelbina in combination with radiotherapy for the treatment of midline gliomas (including Diffuse Intrinsic Glioma of the Pontus) in children (Official Gazette no. 25A03489).

Scientific Rationale

Diffuse midline glioma is one of the poorest prognosis pediatric brain malignancies, with a median survival historically of less than 12 months.
The approval is based on data first produced by the INT of Milan and subsequently replicated in national and international multicenter studies that have documented an improvement in median survival from 10 to 14.5 months thanks to the introduction of the therapeutic combination – Nimotuzumab (anti-EGFR monoclonal antibody) and Vinorelbine, in addition to standard radiotherapy.
A subset of patients achieved long-term survival, configuring the possibility of recovery in selected cases.

Practical implications

Nimotuzumab, previously accessible only through special importation, now becomes part of a therapeutic scheme recognized and covered by the National Health Service.
The adoption of this therapeutic combination allows greater uniformity of access to care throughout the country, reducing disparities between centers and regions.
The therapeutic protocol involves the concomitant administration of Nimotuzumab and Vinorelbine during radiotherapy, according to schemes already shared and validated in the AIEOP setting.

Future prospects

The approval of this combination represents the first significant therapeutic advancement for DIPG in more than 50 years.
Continuing clinical and translational research remains a priority in order to identify further innovative strategies and further improve outcomes for this very high-risk patient population.

For operational details and updates on protocols, please consult the official publication and the reference AIEOP documentation.”

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