The European Commission has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
The European Medicines Agency has validated for review the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer harboring mesenchymal-epithelial transition factor gene exon 14 skipping alterations.
Keytruda (pembrolizumab) received accelerated approval from FDA in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
FDA has issued a Draft Guidance for comment describing the agency's proposed recommendations for including relevant information about oncology drug labels that have been approved for use in combination drug regimens.
The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research at FDA plan to take additional steps to increase transparency regarding CDER and CBER's review of the scientific information supporting the issuance of or revisions to an emergency use authorizations.
Agendia Inc. and Paige, are collaborating to co-development treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia's proprietary MammaPrint and BluePrint diagnostic tests for patients with breast cancer.
FDA has approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test Oct. 26 and Nov. 6 as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens.
FDA has issued a final guidance to increase diversity in clinical trials.
The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase translocation.
Lynparza (olaparib) has been approved in the European Union for the first-line maintenance treatment with bevacizumab of patients with homologous recombination deficient-positive advanced ovarian cancer.
