AMERICAN SOCIETY OF CLINICAL ONCOLOGY

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.

The CBCF ALC panel 'The Road to Health Equity' discussed mistrust in clinical trials among Black communities, citing historical abuses like Tuskegee and Henrietta Lacks. Inclusivity in trials is crucial for medical equity, yet Black Americans are underrepresented. Initiatives like EQBMED aim to increase diversity and trust in clinical research.

FDA approves pembrolizumab plus chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial findings showing significant OS improvement.

FDA approves Kisqali (ribociclib) for HR+/HER2- stage II and III early breast cancer, reducing recurrence risk by 25% with endocrine therapy. NATALEE trial results show consistent benefits and well-tolerated safety profile across subgroups, including node-negative patients. Kisqali is under regulatory review worldwide.

CEACAM5 drugs market to grow significantly due to rising cancer diagnoses and clinical trials; no CEACAM5 drugs currently approved. Key companies developing CEACAM5 drugs include Merck KGaA, Sanofi, and Roche. Emerging therapies like SGM-101 and M9140 show promise in clinical trials.