Global Bulletin

Findings from ELM-1 and ELM-2 support the positive opinion for odronextamab as a treatment for relapsed/refractory follicular lymphoma and DLBCL.

The European Commission is expected to decide on approving epcoritamab in relapsed/refractory follicular lymphoma later in 2024.

The approval for osimertinib/chemotherapy by the Japanese Pharmaceuticals and Medical Device Agency was based on results from the phase 3 FLAURA2 trial.

Approved for use in newly diagnosed and previously treated myelofibrosis, momelotinib may addresses key manifestations of the disease.

Data from FRESCO-2 support the approval of fruquintinib for those with previously treated metastatic colorectal cancer in the European Union.

The European Medicines Agency will begin a centralized review process for subcutaneous nivolumab across multiple solid tumor indications.

Golidocitinib monotherapy had a superior clinical benefit in patients with relapsed/refractory peripheral T-cell lymphoma vs existing treatments.

Data from CAPItello-291 support the approval of capivasertib/fulvestrant for ER-positive, HER2-negative breast cancer in the European Union.

Data from the phase 3 ALINA trial support the approval of alectinib for patients with ALK-positive non–small cell lung cancer in the European Union.

The CheckMate -901 trial led to the approval of the nivolumab combination for unresectable or metastatic urothelial carcinoma in the European Union.

CheckMate-8HW assessed the efficacy of first-line nivolumab plus ipilimumab in patients with MSI-H/dMMR metastatic colorectal cancer.

Amivantamab/chemotherapy has been recommended for approval by the CHMP in advanced non–small cell lung cancer with EGFR exon 20 insertion mutations.

Findings from the CheckMate-901 trial support the CHMP’s positive opinion of nivolumab plus chemotherapy in metastatic urothelial carcinoma.

Those with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer can now receive enzalutamide in the European Union.

Findings from the phase 3 CARTITUDE-4 trial support the European approval of ciltacabtagene autoleucel for relapsed/refractory multiple myeloma.

A series of phase 3 findings support the European approval of tislelizumab as a first-line and second-line treatment for non–small cell lung cancer.

Preliminary findings from the MB-106 trial support the potential benefit of annamycin/cytarabine in patients with acute myeloid leukemia.

Toripalimab plus axitinib is now an approved regimen in China for patients with medium- to high-risk unresectable or metastatic renal cell carcinoma.

Data from a phase 3b trial support a supplemental new drug application in China for savolitinib in previously treated non–small cell lung cancer with MET exon 14 alterations.

Data from the phase 3 COMMANDS trial support the expanded European approval of frontline luspatercept for transfusion-dependent anemia in lower-risk myelodysplastic syndromes.

The characteristics of rare earth ceramics may yield more consistent microwave energy penetration during the treatment of those with thyroid nodules.

Data from the phase 3 EV-302 trial support an application for enfortumab vedotin plus pembrolizumab as a treatment for patients with advanced bladder cancer in China.

Findings from the phase 3 CAPItello-291 trial support the approval of capivasertib/fulvestrant for patients with hormone receptor–positive, HER2-negative breast cancer in Japan.

Data from the phase 3 KEYNOTE-671 trial support the European Commission’s approval of pembrolizumab plus chemotherapy for those with resectable non–small cell lung cancer.

The positive opinion is supported by findings from the phase 3 EMBARK trial assessing enzalutamide in patients with biochemically recurrent prostate cancer.

Data from the phase 3 KarMMa-3 trial support the approval of idecabtagene vicleucel for relapsed/refractory multiple myeloma in the European Union.

Data from the phase 3 RUBY trial support the recommendation for dostarlimab plus chemotherapy for patients with advanced MSI-H/dMMR endometrial cancer.

Data from the TROPION-Lung01 and TROPION-Breast01 trials support the EU marketing authorization applications for datopotamab deruxtecan in non–small cell lung cancer and breast cancer, respectively.

Findings from the phase 3 DeFi trial support the marketing authorization application for nirogacestat as a treatment for adult patients with desmoid tumors in the European Union.

Findings from 3 phase 3 trials support the marketing authorization application for tislelizumab as a treatment for patients with non–small cell lung cancer in the European Union.