Selumetinib was recommended for conditional marketing authorisation in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric patients with neurofibromatosis type 1 aged three years and above.
The European Commission has granted conditional marketing authorisation for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen.
Inivata and Agendia Inc. have entered a commercialization agreement for the RaDaR MRD liquid biopsy assay in breast cancer.
FDA has granted an accelerated approval to Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.
FDA has approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
FDA has granted Breakthrough Therapy designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.
European Commission has approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy.
NeoGenomics Inc., a provider of cancer-focused genetic testing services and global oncology contract research services, has launched an Amgen-sponsored testing program to support single-gene molecular testing for the biomarker KRAS G12C for eligible lung cancer patients at no cost to the patient.
FDA has granted accelerated approval to Trodelvy (sacituzumab govitecan) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
FDA has authorized marketing of the GI Genius, the first device that uses artificial intelligence based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.
