Global Oncology

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

China’s NMPA has accepted for review a new drug application for A400/EP0031 in patients with RET fusion–positive non–small cell lung cancer.

INESSS has issued a positive recommendation for the reimbursement of subcutaneous nivolumab across all Health Canada–authorized solid tumor indications.

CHMP has recommended the approval of selumetinib for symptomatic, inoperable plexiform neurofibromas (PNs) in adult neurofibromatosis type 1.

Vorasidenib has been approved by the European Commission for IDH1/2-mutated grade 2 glioma.

The FDA held a Type A meeting for RP1 in advanced melanoma, the AACR released its Annual Cancer Progress Report, and more.

Taletrectinib was approved in Japan for advanced non–small cell lung cancer harboring ROS1 fusions.

The EMA’s CHMP has recommended the approval of subcutaneous pembrolizumab across all indications and perioperative pembrolizumab in locally advanced HNSCC.

The CHMP has recommended the European approval of subcutaneous mosunetuzumab in relapsed/refractory follicular lymphoma.

Vimseltinib earned approval from the European Commission for the treatment of symptomatic, unresectable tenosynovial giant cell tumors.

Optune Lua plus concurrent PD-1/PD-L1 inhibition has been approved in Japan for advanced non–small cell lung cancer after platinum-based chemotherapy.

An HMR risk signature predicted outcomes in multiple myeloma, linked with genomic instability, immune microenvironment, and drug sensitivity.

The NDA seeking approval of KN026 plus chemotherapy in HER2-positive gastric or GEJ cancer has been accepted for review in China.

T-DXd demonstrated durable systemic and intracranial responses in patients with HER2-positive, -low, and -zero breast cancer brain metastases.

Neoadjuvant tislelizumab plus chemotherapy yielded responses in locally advanced cervical cancer.

A new drug application for nadofaragene firadenovec in BCG-unresponsive bladder cancer has been accepted for review in Japan.

Trastuzumab pamirtecan improved progression-free survival in HER2-positive advanced breast cancer after prior trastuzumab and taxane-based chemotherapy.

Frontline amivantamab plus lazertinib generated an OS benefit vs osimertinib in patients with EGFR-mutated NSCLC in the Asia cohort of the MARIPOSA trial.

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.