AMERICAN SOCIETY OF CLINICAL ONCOLOGY

Sanofi's Sarclisa approved by FDA as first-line treatment for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant, in combination with bortezomib, lenalidomide, and dexamethasone.

European Commission approves VYLOY™ (zolbetuximab) for first-line treatment of advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors, extending progression-free and overall survival in Phase 3 trials.

FDA approves isatuximab-irfc plus bortezomib, lenalidomide, and dexamethasone for transplant-ineligible NDMM, supported by phase 3 IMROZ trial showing significant PFS benefit with Isa-VRd vs VRd alone.

FDA approves Sarclisa, the first anti-CD38 therapy, in combination with VRd for newly diagnosed multiple myeloma patients not eligible for transplant, significantly reducing disease progression or death by 40%.

FDA approves isatuximab with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adults not eligible for autologous stem cell transplant, based on the IMROZ trial showing significant PFS benefits and MRD negativity.

Astellas announces EC approval of VYLOY™ (zolbetuximab) for HER2-negative gastric/GEJ adenocarcinoma with CLDN18.2 positivity, extending PFS and OS in Phase 3 trials. Zolbetuximab is the first and only CLDN18.2-targeted therapy in the EU.

FDA clears Eversense 365, the first 1-year CGM for diabetes. Approves lebrikizumab-lbkz for moderate-to-severe atopic dermatitis, benralizumab for eosinophilic granulomatosis with polyangiitis, and ribociclib plus aromatase inhibitor for HR+/HER2- early breast cancer.

CHMP recommends daratumumab SC for newly diagnosed multiple myeloma eligible for ASCT, supported by PERSEUS study showing 60% reduction in risk of disease progression or death with quadruplet regimen.

Phase 1b study of rogaratinib (600 mg) plus atezolizumab (1200 mg) in 153 patients with advanced/metastatic urothelial carcinoma and FGFR3 mRNA overexpression shows a tolerable combination with a high objective response rate, indicating potential broad benefit for FGFR mRNA-positive patients.

The FDA approved ribociclib (Kisqali) in combination with an aromatase inhibitor as an adjuvant treatment for HR+/HER2- stage 2 and 3 early breast cancer patients at high risk of recurrence, including those with node-negative disease. The approval was based on the NATALEE trial, which showed a 25.2% reduction in invasive disease-free survival risk with ribociclib plus aromatase inhibitor compared to aromatase inhibitor alone. Ribociclib therapy should continue for 3 years and is well-tolerated at a 400 mg dose.