Global Bulletin

The agency has recommended approval for subcutaneous pembrolizumab in all previous solid tumor indications, and for pembrolizumab in recurrent HNSCC.

The decision from the Ministry of Health, Labour and Welfare was supported by phase 3 LUNAR trial results showing an OS benefit with Optune Lua in NSCLC.

Patients with recurrent or metastatic cervical cancer in Hong Kong are now eligible to receive treatment with tisotumab vedotin.

Results from the phase 3 KEYNOTE-689 trial supported the agency’s approval of the pembrolizumab/surgery regimen in PD-L1–positive head and neck cancer.

Patients with FRα+, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer may now be eligible for mirvetuximab soravtansine in the UK.

Data from the phase 3 INAVO120 trial support the approval of inavolisib-based treatment for patients with PIK3CA+, ER+/HER2– disease in the EU.

Results from the phase 3 TRIANGLE trial showed prolonged failure-free survival and overall survival with ibrutinib and CIT vs CIT plus ASCT alone.

Results from the AQUILA trial led to the approval of subcutaneous daratumumab for patients with smoldering multiple myeloma at risk of developing the disease.

Data from the phase 3 KEYNOTE-A18 trial support the approval of the pembrolizumab-based regimen for those with stage III to IVA cervical cancer in Canada.

EU approval of the agent is based on results from the phase 2b ReNeu trial, which met its primary end point of confirmed objective response rate in NF1-PN.

Data from the phase 3 BEACON CRC trial support the approval of encorafenib plus cetuximab for this colorectal cancer population in China.

Data from the RATIONALE-309 trial support the European Commission’s approval of frontline tislelizumab plus chemotherapy in this patient population.

Data from the HERIZON-BTC-01 trial evaluating zanidatamab in previously treated, unresectable HER2-positive biliary tract cancer support the decision.

Data from the phase 3 ASTRUM-005 trial support the MHRA’s approval of serplulimab for patients with extensive-stage small cell lung cancer.

Data from the phase 3 CABINET trial support the CHMP’s positive opinion of cabozantinib in well-differentiated extrapancreatic or pancreatic NETs.

Results from the phase 3 DeFi trial showed superior progression-free survival with nirogacestat vs placebo in patients with progressing desmoid tumors.

In the phase 3 MANEUVER trial, pimicotinib improved the objective response rate vs placebo in patients with tenosynovial giant cell tumor.

In patients with advanced Hodgkin lymphoma, BrECADD was noninferior to eBEACOPP chemotherapy and demonstrated improved progression-free survival.

The European Commission is expected to approve the belantamab mafodotin combinations for this multiple myeloma population in the third quarter of 2025.

The EMA’s CHMP has adopted a positive opinion for mirdametinib in patients with inoperable plexiform neurofibromas of neurofibromatosis type 1.

The positive CHMP opinion is based on results from the phase 1b/2 FELIX trial evaluating obe-cel in relapsed/refractory B-cell ALL.

Tafasitamab is the first CD19 antibody approved in China for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

Findings from the CheckMate 77T study support the approval of this nivolumab-based regimen in the European Union.

Data from the DREAMM-7 and DREAMM-8 trials support the approval of belantamab mafodotin for patients with relapsed/refractory multiple myeloma in Japan.

Support for the decision follows a positive opinion from the Committee for Medicinal Products for Human Use based on the phase 3 ECHO trial results.

The EU approval was based on results from the phase 1/2 LINKER-MM1 trial assessing the efficacy of linvoseltamab in relapsed/refractory multiple myeloma.

Results from the phase 3 HD21 trial showed that brentuximab vedotin plus chemotherapy was superior to alternative treatments in Hodgkin lymphoma.

Data from the phase 3 LUNAR trial support the Conformité Européenne Mark for tumor treating fields in metastatic non–small cell lung cancer.

Results from the DREAMM-7 and DREAMM-8 trials support the approval of belantamab mafodotin with chemotherapy in relapsed/refractory multiple myeloma.

Data from the phase 3 CEPHEUS trial support the European Commission’s approval of the daratumumab-based regimen.