Global Bulletin

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.

Data from the phase 3 EV-302 trial support the supplemental biologics license application for enfortumab vedotin plus pembrolizumab for patients with advanced or metastatic urothelial cancer in Japan.

Data from the phase 3 MARIPOSA study support the Type II application for amivantamab plus lazertinib as a treatment for those with EGFR-mutated non–small cell lung cancer.

Tisotumab vedotin may become the first antibody drug conjugate to receive marketing authorization in the European Union as a treatment for those with cervical cancer.

Findings from the phase 1/2 LINKER-MM1 trial support the marketing authorization application for linvoseltamab in the management of relapsed/refractory multiple myeloma.

A positive CHMP opinion may lead to an approval of idecabtagene vicleucel in the European Union for patients with relapsed/refractory multiple myeloma.

Results from the phase 3 MOMENTUM trial led momelotinib to being approved by the European Commission for patients with myelofibrosis plus anemia and splenomegaly.

Supporting data for the EMA comes from the phase 3 EV-302 trial, which assessed the efficacy of enfortumab vedotin in combination with pembrolizumab compared with chemotherapy.

Findings from the phase 1b/3 IMscin001 study support the European Commission’s approval of subcutaneous atezolizumab as a treatment for lung cancer and other disease types.

Results from the phase 2 KRYSTAL-1 trial led to the approval of adagrasib for patients with KRAS G12C–mutated non–small cell lung cancer by the European Commission.

Sugemalimab is now approved for managing esophageal squamous cell carcinoma in China following results from the phase 3 GEMSTONE-304 study.