EMA extends Durvalumab’s Therapeutic Indications

The European Medicines Agency (EMA’s) Committee for Medicinal Products for Human Use (CHMP) suggested an alteration to the terms of the marketing authorization for the medicinal product durvalumab on 23 July 2020.

An extension to the existing therapeutic indication was adopted by CHMP as follows:

As monotherapy, durvalumab is indicated for managing locally advanced, unresectable non-small cell lung cancer (NSCLC) in individuals whose tumors express PD-L1 on ≥1% of tumor cells and whose disease has not advanced after platinum-based chemoradiation therapy.

In combination with etoposide drug and either cisplatin or carboplatin drug, durvalumab is advocated as the first-line management of individuals having extensive-stage SCLC.

In the updated summary of product characteristics, the detailed recommendations for using this product will be elucidated. After European Commission grants a decision on this modification to the marketing authorization, it will be instantly issued in the revised European public assessment report. This will be then officially available in all the European Union languages.

The summaries of positive opinions will normally be published 67 days from the adoption of the viewpoint and are issued without prejudice to the European Commission decision.