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

Stay up-to-date with the latest regulatory milestones shaping cancer care across Europe. Below is your guide to all oncologic therapies approved by the European Commission (EC) in July 2025, including the pivotal clinical data behind each decision. Read on to learn more!

7/1: Zanidatamab in Pretreated HER2+ Biliary Tract Cancer

The EC granted conditional marketing authorization to the HER2-directed bispecific antibody zanidatamab-hrii (Ziihera) for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive (immunohistochemistry [IHC] 3+) biliary tract cancer (BTC) who received at least 1 previous line of systemic therapy.1

Data from the phase 2b HERIZON-BTC-01 trial (NCT04466891) supported this regulatory decision. In cohort 1 (n = 80), at a median follow-up of 21.9 months, the confirmed overall response rate (ORR) per independent central review (ICR) was 41.3% (95% CI, 30.4%-52.8%); this included 2 patients who achieved a complete response. The median overall survival (OS) was 15.5 months (95% CI, 10.4-18.5), and the median duration of response (DOR) was 14.9 months (95% CI, 7.4-not reached).

With this approval, zanidatamab is now the first HER2-targeted therapy to receive conditional approval for HER2-positive BTC in the European Union (EU). Its continued approval for this indication is contingent upon validation of clinical benefit in the phase 3 HERIZON-BTC-302 trial (NCT06282575).

7/10: First-Line Tislelizumab Plus Chemo for Metastatic Nasopharyngeal Carcinoma

The EC approved tislelizumab (Tevimbra) plus gemcitabine/cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma that is not amenable to curative surgery or radiotherapy.2

Results from the phase 3 RATIONALE-309 trial (NCT03924986) supported this regulatory decision. At the time of the first prespecified interim analysis, tislelizumab plus gemcitabine/cisplatin produced a 48% reduction in the risk of disease progression or death in the intent-to-treat (ITT) population (HR 0.52; 95% CI, 0.38-0.73; P < .0001). The median progression-free survival (PFS) was 9.2 months vs 7.4 months in the tislelizumab vs placebo arms, respectively.

7/21: Obe-Cel for Adult R/R B-Cell Precursor Acute Lymphoblastic Leukemia

Obecabtagene autoleucel (obe-cel; Aucatzyl) won European approval for the treatment of adult patients 26 years of age or older with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL), based on data from the phase 1/2 FELIX trial (NCT04404660).3

FELIX showed that in cohort 2A (n = 94), the complete response/complete response with Incomplete Haematological Recovery (CR/CRi) for patients who received at least one infusion of obe-cel was 76.6%. The median DOR for all infused patients was 21.2 months, and the median event-free survival (EFS) was 11.9 months. The estimated 6- and 12-month EFS rates were 65.4% and 49.5%, respectively.

7/21: Mirdametinib for NF1-Associated Plexiform Neurofibromas

The EC granted conditional marketing authorization to mirdametinib (Ezmekly) for the treatment of adult and pediatric patients 2 years of age and older with symptomatic, inoperable neurofibromatosis type 1 (NF1)–associated plexiform neurofibromas.4

Findings from the phase 2b ReNeu trial (NCT03962543) showed that the confirmed ORR in adult patients (n = 58), as determined by blinded independent central review, was 41% (n = 24/58). For pediatric patients (n = 56), the ORR was 52%. The median best percentage change in target lesion size was –41% (range, –90% to 13%) and –42% (range, –91% to 48%) in these respective patient populations.

Among adult patients with a confirmed response, a DOR of at least 12 months occurred in 88%, and 50% maintained their response for at least 24 months. In pediatric patients, 90% had a response lasting 12 months or longer, and 48% had a response lasting at least 24 months.

7/23: Subcutaneous Daratumumab in Smoldering Myeloma

The EC approved the subcutaneous formulation of daratumumab (Darzalex) monotherapy for the treatment of patients with smoldering multiple myeloma at high risk for developing multiple myeloma.5

The approval was supported by data from the phase 3 AQUILA study (NCT03301220), in which patients treated with fixed-duration subcutaneous daratumumab monotherapy (n = 194) demonstrated statistically significant improved PFS vs patients who underwent active monitoring (n = 196). At a median follow-up of 65.2 months (range, 0-76.6), the 60-month PFS rate was 63.1% vs 40.8% in the daratumumab and active monitoring arms, respectively (HR, 0.49; 95% CI, 0.36-0.67; P < .001).

7/23: Inavolisib Plus Palbociclib/Fulvestrant in PIK3CA-Mutant, HR+/HER2– Advanced Breast Cancer

The combination of inavolisib (Itovebi) with palbociclib (Ibrance) and fulvestrant (Faslodex) was approved by the EC for the treatment of patients with PIK3CA-mutated, estrogen receptor (ER)–positive, HER2-negative, locally advanced or metastatic breast cancer after recurrence on or within 12 months of completing adjuvant endocrine therapy.6

The approval was supported by data from the phase 3 INAVO120 trial (NCT04191499). Findings published in the New England Journal of Medicine in October 2024 showed that patients treated with the inavolisib-based regimen in the first line achieved a 57% reduction in the risk of disease worsening or death vs palbociclib and fulvestrant alone, at 15.0 months vs 7.3 months, respectively (HR, 0.43; 95% CI: 0.32-0.59, P < 0.001). This PFS benefit was consistent across all prespecified subgroups.

7/24: Belantamab Mafodotin Combos in R/R Myeloma

The EC granted approval to belantamab mafodotin (Blenrep) plus bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; and in combination with pomalidomide (Pomalyst) and dexamethasone (BPd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy, including lenalidomide (Revlimid).7

Data from the phase 3 DREAMM-7 (NCT04246047) and DREAMM-8 trials (NCT04484623), respectively, supported these approvals. In both studies, the belantamab mafodotin–based combinations demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) vs standard-of-care triplet regimens.

7/24: Cabozantinib for Previously Treated Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

Cabozantinib (Cabometyx) received approval from the EC for adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors (NETs) who have progressed following at least 1 prior systemic therapy other than somatostatin analogues.8

Final results from the pivotal phase 3 CABINET trial (NCT03375320)​​ supported the agent’s approval, demonstrating a 77% and 62% reduction in the risk of disease progression or death with cabozantinib vs placebo in the pNET (n = 95) and epNET (n = 203) cohorts, respectively.

Of note, this regulatory decision marks cabozantinib as the first and only systemic therapy to be approved in the EU for patients with previously treated unresectable or metastatic NETs, regardless of tumor site, grade, or previous non–somatostatin analogue–based systemic therapy.

7/25: Isatuximab Plus VRd for Transplant-Eligible Newly Diagnosed Multiple Myeloma

Isatuximab-irfc (Sarclisa) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (Isa-VRd) as induction therapy was approved for adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.9

The approval was supported by results from part 1 of the phase 3 German-speaking Myeloma Multicenter Group (GMG)-HD7 study (NCT03617731), in which Isa-VRd improved minimal residual disease (MRD)–negativity rates at the end of the 18-week induction period in transplant-eligible patients with newly diagnosed multiple myeloma, thereby meeting the primary end point of part 1.

Additional Regulatory Decisions of Note:

7/2: Denosumab Biosimilar in Advanced Malignancies Involving the Bone and Giant Cell Tumors of the Bone

The denosumab (Xgeva) biosimilar Denbrayce was approved by the EC for the prevention of skeletal-related events in adult patients with advanced malignancies involving the bone and in adult and skeletally mature adolescent patients with giant cell tumor of the bone.10

7/23: Ibrutinib in Treatment-Naive, Transplant-Eligible MCL

The European Commission expanded the indication for ibrutinib (Imbruvica) for use in combination with R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, and prednisolone) alternating with R-DHAP (rituximab, dexamethasone, high-dose cytarabine, and cisplatin) or R-DHAOx (rituximab, dexamethasone, high-dose cytarabine, and oxaliplatin) without ibrutinib, followed by ibrutinib monotherapy, for the frontline treatment of patients with mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant.11 Data from the phase 3 TRIANGLE trial (NCT02858258) supported this expanded approval.

References

1. Jazz Pharmaceuticals receives European Commission marketing authorization for Ziihera (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer. News release. Jazz Pharmaceuticals. July 1, 2025. Accessed August 5, 2025. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-receives-european-commission-marketing
2. European Commission approves Tevimbra in combination with chemotherapy as a first-line treatment for nasopharyngeal carcinoma. News release. BeOne. July 10, 2025. Accessed August 5, 2025. https://ir.beonemedicines.com/news/european-commission-approves-tevimbrar-in-combination-with-chemotherapy-as-a-first-line-treatment-for-nasopharyngeal-carcinoma/3ed59f18-6818-4ab5-8c33-3ce2b78144df
3. Autolus Therapeutics’ CAR T therapy Aucatzyl (obecabtagene autoleucel) granted European marketing authorization for adult patients (age 26 and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL). News release. Autolus Therapeutics. July 21, 2025. Accessed August 5, 2025. https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-car-t-therapy-aucatzylr-obecabtagene
4. The European Commission has granted conditional approval of Ezmekly (mirdametinib) for the treatment of adult and pediatric patients with neurofibromatosis type 1–associated plexiform neurofibromas (NF1-PN). News release. SpringWorks Therapeutics. July 18, 2025. Accessed August 5, 2025. https://springworkstx.gcs-web.com/news-releases/news-release-details/european-commission-grants-conditional-approval-ezmeklyr
5. European Commission approves Darzalex (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma. News release. Johnson & Johnson. July 23, 2025. Accessed August 5, 2025. https://www.jnj.com/media-center/press-releases/european-commission-approves-darzalex-daratumumab-as-the-first-licensed-treatment-for-patients-with-high-risk-smouldering-multiple-myeloma
6. European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation. News release. Roche. July 22, 2025. Accessed August 5, 2025. https://www.roche.com/media/releases/med-cor-2025-07-23
7. Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma. News Release. GSK. July 24, 2025. Accessed August 5, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/
8. Cabometyx approved in the EU for previously treated advanced neuroendocrine tumors. Ipsen. July 24, 2025. Accessed August 5, 2025. https://ml-eu.globenewswire.com/Resource/Download/1f6cb083-99c6-45eb-95ff-fa79a990f6f4
9. Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma. News release. Sanofi. July 25, 2025. Accessed August 5, 2025.https://www.sanofi.com/en/media-room/press-releases/2025/2025-07-25-05-00-00-3121591
10. mAbxience announces European Commission approval of denosumab biosimilars. News release. mAbxience. July 2, 2025. Accessed August 5, 2025. https://mabxience.com/mabxience-announces-european-commission-approval-of-denosumab-biosimilars/
11. European Commission approves Imbruvica (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant. News release. Johnson & Johnson. July 23, 2025. Accessed August 5, 2025. https://www.jnj.com/media-center/press-releases/european-commission-approves-imbruvica-ibrutinib-as-the-first-targeted-therapy-for-patients-with-previously-untreated-mantle-cell-lymphoma-who-would-be-eligible-for-autologous-stem-cell-transplant