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Europe's drug advisory committee has recommended three new cancer treatments for EU approval. Ensartinib targets ALK-positive lung cancer, while relacorilant and senaparib offer new options for ovarian cancer patients. Full European Commission authorization is expected by Q4 2026.
Europe's drug advisory body, the EMA's CHMP, has recommended marketing authorization for three oncology medicines at its September 2026 meeting. The trio targets two solid tumor types: ALK-positive non-small cell lung cancer (NSCLC) and epithelial ovarian/fallopian tube/peritoneal cancers. If the European Commission gives the final green light — typically within ~67 days — all three could be available across the EU by Q4 2026.
Here's the breakdown of each drug: Gevalka (ensartinib) is an oral ALK inhibitor for ALK-positive advanced NSCLC. In the phase 3 eXalt3 trial, it nearly doubled progression-free survival vs. crizotinib and dramatically improved intracranial response rates. Lifyorli (relacorilant), a glucocorticoid receptor antagonist, is used with nab-paclitaxel for platinum-resistant ovarian cancer, improving both PFS and overall survival without requiring biomarker selection. Sepalna (senaparib), a PARP inhibitor, is a maintenance therapy after first-line platinum-based chemo, cutting the risk of progression or death by 57% regardless of BRCA status.
By the Numbers:
Why it matters: These approvals would meaningfully expand the EU oncology toolkit — offering a stronger first-line ALK inhibitor, a chemo-sensitizing combo for hard-to-treat ovarian cancer, and a biomarker-agnostic maintenance PARP inhibitor — addressing significant unmet needs across both tumor types.