At its September 2026 meeting, European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for three oncology medicines: Gevalka (ensartinib, SFL Pharmaceuticals), Lifyorli (relacorilant, Corcept Therapeutics), and Sepalna (senaparib, SFL Pharmaceuticals). The medicines address different stages of two solid tumor types: ALK-positive non-small cell lung cancer (NSCLC) and epithelial ovarian, fallopian tube, or primary peritoneal cancer. If approved by the European Commission, all three agents would be authorized across the EU in the coming months.

Gevalka 

Gevalka is an oral ALK TKI available as 25-mg and 100-mg capsules. The drug works by inhibiting phosphorylation of ALK and its downstream signaling, thereby preventing proliferation of ALK-dependent cancer cells.  

The opinion covers two populations: patients with ALK-positive advanced NSCLC who have not previously been treated with an ALK inhibitor, and those previously treated with crizotinib.

The first-line benefit of Gevalka is based on the phase 3 eXalt3 trial in which 290 treatment-naive patients with locally advanced or metastatic ALK-positive NSCLC were assigned to receive ensartinib or crizotinib. Median progression-free survival was 25.8 months with ensartinib vs 12.7 months with crizotinib (hazard ratio, 0.51). Objective response rates were 74% with ensartinib vs 67% with crizotinib, and intracranial response rates were 63.6% vs 21.1%, respectively. Gevalka was also effective in patients previously treated with crizotinib. The most common side effects are rash, liver function test abnormalities, pruritus, and nausea. 

Lifyorli 

Lifyorli is a selective, reversible glucocorticoid receptor (GR) antagonist. By inhibiting GR signaling, it may enhance tumor sensitivity to chemotherapy. In xenograft models, relacorilant increased the antitumor activity of chemotherapy, supporting its potential to overcome GR-mediated mechanisms of treatment resistance. The CHMP opinion covers Lifyorli in combination with nab-paclitaxel for adults with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.  

Supporting evidence included data from the phase 3 ROSELLA trial, which enrolled 381 heavily pretreated patients (all had received prior bevacizumab, and roughly 6 in 10 had received a PARP inhibitor). Patients were randomly assigned to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The combination significantly improved progression-free survival (PFS), with a hazard ratio of 0.70 and median PFS of 6.54 months vs 5.52 months. A subsequent final analysis of the trial’s other dual primary endpoint showed the combination also significantly extended overall survival, without requiring biomarker selection, with median overall survival of 16.0 months. The safety profile was consistent with nab-paclitaxel monotherapy.

The most common side effects with Lifyorli include anemia, nausea, diarrhea, neutropenia, constipation, asthenia, abdominal pain, fatigue, and decreased appetite.

Sepalna

Sepalna is a PARP inhibitor that blocks the repair of damaged DNA in cancer cells, causing the cancer cells to die. It is supplied as 20-mg hard capsules. The CHMP opinion supports its use as maintenance treatment in adults with advanced epithelial high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy, with the benefit being an improvement in progression-free survival compared with placebo.  

Among the supporting evidence were results from the phase 3 FLAMES trial, in which 404 patients received either senaparib or placebo after response to first-line platinum-based chemotherapy. The benefit did not depend on biomarker status: median PFS was not reached with senaparib vs 13.6 months with placebo, reflecting a 57% reduction in the risk for progression or death, consistent across BRCA1/2 and homologous recombination subgroups. Grade 3 or higher adverse events occurred in 66.3% of senaparib-treated patients vs 20.3% with placebo, though discontinuation for toxicity remained low. 

The most common side effects with Sepalna include anemia, leukopenia, neutropenia, thrombocytopenia, nausea, increased aminotransferase levels, fatigue, abdominal pain, vomiting, dizziness, diarrhea, decreased appetite, lymphopenia, upper respiratory tract infection, hematuria, increased gamma-glutamyltransferase, hyperbilirubinemia, headache, and arthralgia.

Next Steps

According to the CHMP, these treatments must be initiated and supervised by a physician experienced in the use of anticancer medicinal products. All three positive opinions now move to the European Commission, which typically finalizes marketing authorization decisions within about 67 days of a CHMP recommendation, placing likely EU approval for all three medicines around the fourth quarter of 2026. Following approval, prescribing information, including guidance on patient selection, dosing, and safety monitoring, will be published in the medicines’ Summary of Product Characteristics in all official EU languages.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.