Europe – European Commission grants AstraZeneca three new approvals

The European Commission (EC) has granted AstraZeneca three new drug approvals, with the company’s Imfinzi/Imjudo immunotherapy combinations authorised for advanced liver and lung cancers, and a tablet formulation of Calquence for chronic lymphocytic leukaemia (CLL).

The Imfinzi/ Imjudo approvals authorise the combination to be used for the first line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC), with the addition of platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC).

The EC’s decision, which follows a recommendation by the Committee for Medicinal Products for Human Use (CHMP) in December, was supported by positive results from the HIMALAYA and POSEIDON phase 3 trials.

In HIMALAYA, the combination was associated with a significant reduction in the risk of death in HCC patients, at 22% versus standard of care sorafenib…