Global Bulletin

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.

Belumosudil is the first therapy within England and Wales available for the treatment of patients 12 years and older who have previously undergone a minimum of 2 lines of systemic treatment.

In Europe, pembrolizumab is now available as a treatment in combination with fluoropyrimidine-/platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, as well as in combination with gemcitabine/cisplatin for locally advanced biliary tract carcinoma.

The European approval for dostarlimab and chemotherapy for dMMR/MSI-H, primary advanced or recurrent endometrial cancer is based on data from part 1 of the phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO trial.

Data from the phase 1b/3 IMscin001 trial support the Committee for Medicinal Products for Human Use’s positive opinion on subcutaneous atezolizumab in lung cancer and other disease types.

Adagrasib, which now has a positive CHMP opinion, was previously examined as part of the phase 1/2 KRYSTAL-1 study.

If momelotinib receives approval in the European Union, it will become the only agent for the treatment of myelofibrosis coupled with moderate to severe anemia.

Data from the phase 3 RUBY/ENGOT-EN6/GOG3031/NSGO trial support the use of frontline dostarlimab plus chemotherapy for dMMR/MSI-H primary advanced or recurrent endometrial cancer.