Global Oncology

The EMA has validated a Type II variation application for trastuzumab deruxtecan plus pertuzumab in first-line HER2-positive metastatic breast cancer.

CPI-008 received orphan drug designation from the FDA and EMA for margin detection of pancreatic cancer during surgery.

Sac-TMT plus pembrolizumab has earned breakthrough therapy designation in China in frontline EGFR- and ALK-negative PD-L1+ NSCLC.

The FDA cleared narsoplimab for TA-TMA, an NDA seeking approval of bezuclastinib in nonadvanced systemic mastocytosis has been submitted, and more.

China’s NMPA approved ipilimumab N01 plus sintilimab as neoadjuvant therapy for stage IIB to III resectable MSI-H/dMMR colon cancer.

Japan’s Ministry of Health, Labour and Welfare has approved tafasitamab plus rituximab and lenalidomide for relapsed/refractory follicular lymphoma.

The FDA approved subcutaneous mosunetuzumab for relapsed/refractory follicular lymphoma and granted a pair of breakthrough therapy designations.

The NMPA of China has approved pimicotinib, a CSF-1R inhibitor, for the treatment of adults with symptomatic TGCT.

The NMPA has accepted a new drug application for tinengotinib tablets for the treatment of patients with pretreated advanced/metastatic cholangiocarcinoma.

The EMA recommended conditional marketing authorization for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with CIS.

Antonio González-Martín, MD, PhD, discusses data for TUB-040 in platinum-resistant ovarian cancer and how it stacks up against other ADCs.

Pembrolizumab obtained approval from the European Commission for subcutaneous administration for all adult indications.

NICE has recommended obecabtegene autoleucel for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Liso-cel was approved in the EU for relapsed/refractory MCL after at least 2 lines of therapy, including a BTK inhibitor.

Sacituzumab tirumotecan plus pembrolizumab improved PFS as first-line treatment in PD-L1–positive advanced NSCLC.

The European Commission has approved subcutaneous mosunetuzumab for relapsed/refractory follicular lymphoma.

Cemiplimab wins EU approval after C-POST shows DFS gains for high-risk CSCC, marking the first effective adjuvant immunotherapy option.

PanTRKare was approved in China as a companion diagnostic to identify patients with NTRK fusion–positive solid tumors who may be eligible for entrectinib.

Phase 2 data showed high 2-year survival and deep MRD-negative remissions with a CD22/CD19 CAR T-cell therapy and ASCT “sandwich” approach in B-ALL.

Ivonescimab plus chemotherapy has received breakthrough therapy designation as first-line therapy in patients with triple-negative breast cancer.

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

Seven provinces have agreed to reimburse cemiplimab for the treatment of patients with advanced non–small cell lung cancer and basal cell carcinoma.

Mirvetuximab soravtansine has received a positive reimbursement recommendation in Canada under the Target Zero initiative for platinum-resistant ovarian cancer.

The European Commission approved perioperative pembrolizumab plus adjuvant radiotherapy with or without cisplatin in resectable locally advanced HNSCC.

Selumetinib has received approval in the EU for the management of plexiform neurofibromas in adult patients with neurofibromatosis type 1.