Global

The PD-L1– and VEGF-directed bispecific antibody IMM2510 proved active in patients with squamous NSCLC after prior chemotherapy and immunotherapy.

The marketing authorization application submitted to the EMA for T-DXd in HER2-positive unresectable or metastatic solid tumors has been validated.

Orelabrutinib has been approved as a treatment option for patients with marginal zone lymphoma in Singapore.

Estelamari Rodriguez, MD, MPH, Coral Olazagasti, MD, and Tina Roy, MD, sit down with Chandler Park, MD, FACP, to discuss the latest abstracts in lung cancer presented during the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer.

Narjust Florez, MD, and Joshua K. Sabari, MD, sit down with Chandler Park, MD, FACP, to discuss the latest abstracts in lung cancer presented during the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer.

Luis E. Raez, MD, and Suresh S. Ramalingam, MD, FACP, FASCO, sit down with Chandler Park, MD, FACP, and Eric K. Singhi, MD, to discuss the latest abstracts in lung cancer presented during the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer.

The VENTANA HER2 (4B5) test earned CE-IVDR approval in Europe to assess HER2 status in metastatic breast cancer and biliary tract cancer.

Tisotumab vedotin is cleared in Hong Kong for the treatment of select patients with cervical cancer.

The MMR IHC Panel pharmDx was certified in the EU as a companion diagnostic to identify patients with colorectal cancer eligible for nivolumab/ipilimumab.

Health Canada approved mirvetuximab soravtansine for folate receptor-alpha positive, platinum-resistant epithelial ovarian cancer.

Here is your snapshot of all oncologic therapeutic options that were approved by the EMA in August 2025.

China’s NMPA approved zongertinib tablets for unresectable, locally advanced or metastatic, previously treated NSCLC with HER2 mutations.

The EMA granted orphan designation to ADX-2191 for the management of LBCL of immune-privileged sites, including primary vitreoretinal lymphoma.

The combination of anlotinib plus chemotherapy has been approved in China for the treatment of patients with advanced soft tissue sarcoma.

As the FDA aims to reduce drug review times, the 15% tariff rate imposed on pharmaceuticals from Europe could affect drug access in the oncology space.

The European Commission approved neoadjuvant tislelizumab plus chemotherapy, followed by adjuvant tislelizumab, for resectable non–small cell lung cancer.

UM171 cell therapy has earned European Commission approval for the treatment of patients with hematologic malignancies requiring HSCT.

Ivonescimab plus chemotherapy improved overall survival in previously treated, advanced non–small cell lung cancer harboring EGFR mutations.

Trastuzumab deruxtecan has been approved in Japan for patients with HR+, HER2-low or -ultralow metastatic breast cancer.

Datopotamab deruxtecan is approved in China for hormone receptor–positive, HER2-negative metastatic breast cancer after prior endocrine therapy and chemotherapy.

Pegtarazimod has received orphan drug designation from the European Medicines Agency for the management of graft-vs-host disease.

Venetoclax plus obinutuzumab generated safe and efficacious real-world outcomes in first-line CLL with comorbidities.

Health Canada has granted marketing authorization to darolutamide for the treatment of adult patients with metastatic castration-sensitive prostate cancer.

Glofitamab plus GemOx received approval in Canada for patients with relapsed or refractory DLBCL not otherwise specified who are not eligible for ASCT.

The European approval of a zanubrutinb tablet formulation covers indications in CLL, Waldenström macroglobulinemia, MZL, and follicular lymphoma.

Alpha1H met all primary and secondary end points in a phase 2 study in non–muscle-invasive bladder cancer.

Nivolumab plus ipilimumab earned approval from Health Canada for select patients with unresectable colorectal cancer and hepatocellular carcinoma.

The NMPA has granted breakthrough therapy designation to ATG-022 for previously treated gastric and gastroesophageal junction adenocarcinoma.

The European Commission approved nirogacestat for the treatment of progressing desmoid tumors requiring systemic treatment.

PLD plus ifosfamide produced an ORR of 33% and a DCR of 83% in advanced soft tissue sarcoma, with manageable toxicity.