EMA cancer therapy approval recommendations

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive recommendations for several new cancer therapies.

Initially, the CHMP recommended the approval of Lifyorli (relacorilant) in combination with nab-paclitaxel for treating platinum-resistant, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. This recommendation followed data from the phase 3 ROSELLA trial and a phase 2 study, which indicated improved survival outcomes for patients using the combination therapy compared to those receiving nab-paclitaxel alone.

Subsequently, the CHMP expanded its recommendations to include three therapies: ensartinib (Gevalka), relacorilant (Lifyorli), and senaparib (Sepalna). Ensartinib is a targeted ALK tyrosine kinase inhibitor for advanced ALK-positive non-small cell lung cancer (NSCLC), showing a significant reduction in the risk of disease progression or death in clinical studies. Relacorilant serves as a selective and reversible glucocorticoid receptor antagonist for ovarian cancer.