EMA recommends approval for three new lung and ovarian cancer therapies

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of three new cancer therapies: ensartinib (Gevalka), relacorilant (Lifyorli), and senaparib (Sepalna). Once finalized by the European Commission, these treatments will be available across all EU member states.

Ensartinib is a targeted ALK tyrosine kinase inhibitor designed for patients with advanced ALK-positive non-small cell lung cancer (NSCLC). Clinical data from the phase III eXalt3 study involving 290 patients showed a median progression-free survival of 25.8 months with ensartinib, compared to 12.7 months with crizotinib, representing a 49% reduction in the risk of disease progression or death. The drug also demonstrated high intracranial activity.

Relacorilant introduces a different strategy as a selective and reversible glucocorticoid receptor (GR) antagonist, aimed at addressing platinum-resistant ovarian cancer.