Global Bulletin

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.

The European Medicine Agency’s Committee for Medicinal Products for Human Use’s recommendation of approving pembrolizumab plus chemotherapy in resectable non–small cell lung cancer is based on results from the KEYNOTE-671 trial.