23/04/2026
https://www.esmo.org/oncology-news/ema-recommends-granting-a-marketing-authorisation-for-tarlatamab
Finalmente una buona notizia anche per i tumori Neuroendocrini piu' aggressivi: l'E.M.A., l'Agenzia Europea del farmaco ha autorizzato il farmaco TARLATAMAB per il trattamento del "microcitoma" o "carcinoma del polmone a piccole cellule"in fase avanzata. Di seguito il comunicato ufficiale da ESMO news che potete trovare anche cliccando sul link, vista l'aggressivita' della neoplasia e le poche alternative terapeutiche A.I. NET auspica un iter di approvazione celere anche in Italia
"....the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product tarlatamab (Imdylltra), intended for the treatment of extensive-stage small cell lung cancer (SCLC).
The active substance of Imdylltra is tarlatamab, an antineoplastic agent. Tarlatamab is a bispecific T-cell engager targeting DLL3, an oncogenic protein aberrantly expressed by SCLC tumour cells, and CD3 expressed by T cells. This activates T cells and leads to the production of inflammatory cytokines and the release of cytotoxic proteins, resulting in tumour cell death.
The benefits of Imdylltra are a statistically and clinically significant improvement in overall survival, and a 40% reduction in the risk of death with Imdylltra compared with the active comparator arm, based on an ongoing, randomised, open-label, multicentre phase III study comparing tarlatamab to standard-of-care in adults with relapsed SCLC after platinum-based first-line chemotherapy.
The most common side effects with Imdylltra include cytokine release syndrome, decreased appetite and pyrexia.
Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage SCLC, who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
Imdylltra treatment should be initiated under the direction of and supervised by physicians experienced in the use of cancer therapy. It should be administered in an appropriate healthcare facility.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained."
