Global Bulletin

The European Medicines Agency has begun a phased review of daraxonrasib for pancreatic cancer as the FDA nears completion of a rolling new drug application submission.

The European Commission approved epcoritamab/R2 for adult patients with relapsed/refractory follicular lymphoma based on the phase 3 EPCORE FL-1 data.

The CHMP recommended pirtobrutinib in chronic lymphocytic leukemia based on data from the phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials.

The CHMP’s recommendation for approving teclistamab plus daratumumab in this multiple myeloma population is based on data from the phase 3 MajesTEC-3 study.

Findings from the phase 2 MOR208C203 trial and phase 1b/2 INCMOR 0208-102 trial support the Japanese regulatory decision for tafasitamab in DLBCL.

Findings from the phase 3 EV-303 trial evaluating the enfortumab-based regimen vs surgery alone in this MIBC group supported the regulatory decision.

The clearance enables the developers to include China-based centers in an ongoing phase 1a/1b trial evaluating the agent in late-stage solid tumors.

The approval of the on-body injector in multiple myeloma follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use.

Data from the phase 3 DeLLphi-304 trial support the European Commission’s approval of tarlatamab in extensive-stage small cell lung cancer.

Orelabrutinib is now available in Australia for patients with relapsed/refractory mantle cell lymphoma.

The European Medicine Agency’s CHMP has adopted a positive opinion for encorafenib plus cetuximab and mFOLFOX6 in this treatment-naïve mCRC population.

Data from the phase 3 DREAMM-7 trial support the approval of belantamab mafodotin plus bortezomib and dexamethasone for patients in China.

Data from the POD1UM-303/InterAACT-2 trial support the approval of the retifanlimab regimen in first-line squamous cell carcinoma of the anal canal.

The marketing authorization was based on results from the DESTINY-Breast09 trial assessing T-DXd/pertuzumab in first-line HER2+ metastatic breast cancer.

Data from the QUILT-3.032 trial supported the Saudi approval of nogapendekin alfa plus BCG in adults with BCG-unresponsive NMIBC with carcinoma in situ.

The Taiwan FDA has approved nivolumab/ipilimumab for patients with MSI-H/dMMR metastatic colorectal cancer based on data from CheckMate 8HW.

Data from the QUILT-3.055 and QUILT-2.023 studies support the accelerated approval of the nogapendekin alfa inbakicept regimens in Saudi Arabia.

Data from the phase 3 MANUEVER trial support the approval of pimicotinib for patients in China with symptomatic tenosynovial giant cell tumors.

The tafasitamab-based regimen was previously approved by the FDA in June 2025 for patients with relapsed/refractory follicular lymphoma.

Results from the TRANSCEND NHL 001 trial showed that liso-cel achieved an ORR of 82.7% in patients with previously treated mantle cell lymphoma.

Pharmacokinetic data from the phase 1/2 GO29781 study support the European approval of subcutaneous mosunetuzumab in this follicular lymphoma population.

The regulatory decision regarding the subcutaneous pembrolizumab formulation is based on results from the phase 3 3475A-D77 trial.

The phase 3 KEYNOTE-689 trial showed a median EFS of 59.7 months with the pembrolizumab regimen in locally advanced head and neck squamous cell carcinoma.

Data from the phase 3 DESTINY-Breast09 trial presented at the 2025 ASCO Annual Meeting formed the basis of the supplemental NDA.

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.