OncLive’s October EMA Regulatory Recap: Key EU Approvals in Oncology

Below is your guide to the regulatory milestones that pushed cancer care forward in the European Union in October, featuring key approvals by the European Commission (EC), as well as emerging recommendations from the European Medicines Agency’s (EMA)’s Committee for Medicinal Products for Human Use (CHMP).

This month’s decisions introduced new therapeutic options in tumor types like head and neck cancer and neurofibromatosis type 1 (NF1)–associated plexiform neurofibromas. The updates also highlight potential approvals that could expand access to adjuvant immunotherapy and novel oral targeted therapies. Read on to learn more!

What Were the Key EU Approvals of September 2025?

10/28: Selumetinib Nets EU Approval for Adult NF1-Associated Plexiform Neurofibromas

The EC cleared selumetinib (Koselugo) for the treatment of adult patients with symptomatic, inoperable plexiform neurofibromas (PNs) in adult patients with neurofibromatosis type 1.¹

This decision was based on findings from the phase 3 KOMET trial (NCT04924608), which demonstrated that selumetinib (n = 71) elicited an overall response rate (ORR) of 20% (95% CI, 11.2%-30.9%) vs 5% (95% CI, 1.5%-13.3%) with placebo (P = .0112), meeting the study’s primary end point.^2,3

The benefit was accompanied by meaningful tumor volume reduction and a safety profile consistent with prior pediatric use. No new safety signals were identified. The most common treatment-emergent adverse effects (TEAEs) included dermatitis acneiform (59%), elevated blood creatine phosphokinase levels (42%), and diarrhea (28%).

10/29: Pembrolizumab-Based Combo Wins EU Approval for PD-L1+ Resectable Locally Advanced HNSCC

The European Commission awarded approval to neoadjuvant pembrolizumab (Keytruda) monotherapy, followed by adjuvant pembrolizumab plus radiotherapy with or without concomitant cisplatin, and then single-agent pembrolizumab, for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a combined positive score (CPS) of at least 1.⁴

The decision was supported by data from the phase 3 KEYNOTE-689 trial (NCT03765918), in which the pembrolizumab regimen reduced the risk of recurrence, progression, or death by 30% compared with adjuvant radiotherapy with or without cisplatin alone (HR, 0.70; 95% CI, 0.55–0.89; P = .00140). The median event-free survival in the respective arms was 59.7months (95% CI, 37.9-not reached [NR]) and 29.6 months (95% CI, 19.5-41.9).

The safety profile of pembrolizumab was consistent with prior experience. Treatment-related adverse effects (TRAEs) of any grade occurred in approximately 81% of patients in both study arms, and grade 3 or higher TRAEs occurred in 44.6% of patients treated with pembrolizumab vs 42.9% in the control group.⁵

What Potential Approvals Are Coming Down the Pike?

EU Approval Sought for Relacorilant in Platinum-Resistant Ovarian Cancer

A marketing authorization application (MAA) for relacorilant plus nab-paclitaxel (Abraxane) for use in patients with platinum-resistant ovarian cancer has been submitted to the EMA.⁶
The submission is supported by data from the phase 3 ROSELLA trial (GOG-3073/ENGOT ov72/APGOT-Ov10/LACOG-0223/ANZGOG-2221/2023; NCT05257408) and phase 2 studies, which showed that the addition of relacorilant improved progression-free survival (PFS) and overall survival (OS) vs nab-paclitaxel alone. In ROSELLA, the regimen yielded a median PFS of 6.54 months (95% CI, 5.55-7.43) with the relacorilant combination vs 5.52 months (95% CI, 3.94-5.88) with nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54–0.91; P = .0076) and amedian OS of 15.97 months (95% CI, 13.47-NR) vs 11.50 months (95% CI, 10.02-13.57; HR, 0.69; 95% CI, 0.52-0.92; P = .0121).⁷

The combination was well tolerated, with a safety profile consistent with prior studies.

A new drug application for relacorilant in the same indication is also currently under FDA review, with a Prescription Drug User Fee Act (PDUFA)decision date of July 11, 2026.⁸

Adjuvant Cemiplimab Recommended for European Approval in CSCC

The EMA’s CHMP has issued a positive opinion recommending approval of cemiplimab-rwlc (Libtayo) for adjuvant use in adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.⁹ The EC is expected to make a final decision in the coming months.

The recommendation is supported by data from the phase 3 C-POST trial (NCT03969004), which showed that adjuvant cemiplimab after surgical resection and postoperative radiotherapy (n = 209) significantly improved disease-free survival (DFS) vs placebo (n = 206), reducing the risk of recurrence or death by 68% (HR, 0.32; 95% CI, 0.20-0.51; P < .001).¹⁰ In the respective arms, the median DFS was NR (95% CI, not evaluable [NE]-NE) vs 49.4 months (95% CI, 48.5-NE). At 24 months, DFS rates were 87.1% (95% CI, 80.3%-91.6%) and 64.1% (95% CI, 55.9%-71.1%), respectively.

The safety profile was consistent with prior experience in advanced settings. Any-grade adverse effects occurred in 91.2% and 89.2% of patients in the cemiplimab (n = 205) and placebo (n = 204) arms, respectively, with fatigue (22.0% vs 21.6%), pruritus (16.1% vs 8.8%), and rash (16.1% vs 8.8%) being the most common.

References

1. Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1. News release. AstraZeneca. October 28, 2025. Accessed November 2, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/koselugo-approved-in-the-eu-for-plexiform-neurofibromas-in-adults-with-neurofibromatosis-type-1.html
2. Chen AP, O’Sullivan Coyne GH, Wolters P, et al. Efficacy and safety of selumetinib in adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibroma (PN): primary analysis of KOMET (NCT04924608), a phase 3, international, randomized, placebo-controlled study. J Clin Oncol. 2025;43(suppl 16):3014. doi:10.1200/JCO.2025.43.16_suppl.3014
3. Chen AP, Coyne GO, Wolters PL, et al. Efficacy and safety of selumetinib in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas (KOMET): a multicentre, international, randomised, placebo-controlled, parallel, double-blind, phase 3 study. Lancet. 2025;405(10496):2217-2230. doi:10.1016/S0140-6736(25)00986-9
4. European Commission approves Keytruda (pembrolizumab) as part of a treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) expressing PD-L1 (CPS >1). News release. Merck. October 29, 2025. Accessed November 2, 2025. https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-as-part-of-a-treatment-regimen-for-adults-with-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-la-hnscc-expressing-pd-l1/
5. Uppaluri R, Haddad RI, Tao Y, et al. Neoadjuvant and adjuvant pembrolizumab in locally advanced head and neck cancer. N Engl J Med. 2025;393(1):37-50. doi:10.1056/NEJMoa2415434
6. Corcept submits marketing authorization application to European Medicines Agency for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. October 14, 2025. Accessed November 2, 2025. https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european
7. Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 2025;43(suppl 17):LBA5507. doi:JCO.2025.43.17_suppl.LBA5507
8. Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) with a high risk of recurrence after surgery and radiation. News release. Regeneron. October 17, 2025. Accessed November 2, 2025. https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-recommended-eu-approval-chmp-adjuvant
9. FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. September 10, 2025. Accessed November 2, 2025. https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
10. Rischin D, Porceddu S, Day F, et al. Adjuvant cemiplimab or placebo in high-risk cutaneous squamous-cell carcinoma. N Engl J Med. 2025;393(8):774-785. doi:10.1056/NEJMoa2502449