IQVIA report outlines key 2018 approvals and more
See summary below and click on image to see full IQVIA 2019 report.
"There were 15 therapeutic oncology new active substances (NASs) and one supportive care NAS launched in the United States in 2018. Predictive biomarkers were associated with60% of therapeutic oncology NASs, and three were approved with a companion diagnostic. Precision medicines are having a signi cant impact on the treatment of cancer by stratifying patients into specific groups of patients likely to respond to therapy (or not) via predictive biomarkers.Three NASs were immune-oncology (I/O) therapies: Cemiplimab is a PD-1 inhibitor, while mogamulizumab is a chemokine receptor inhibitor (CCR4) and moxetumomab modulates a tumor-associated antigen (CD22). Mogamulizumab and moxetumomab represent new strategies in I/O therapy that historically has focused on checkpoint inhibitors and less targetedimmunomodulatory mechanisms, such as interferons."
"Ten of the16 therapies are delivered in an oral formulation, decreasing the patient burden of receiving care at an infusion center or hospital.• Although there were only four breakthrough oncology therapies, down from historical high of 11 in 2017, 12 of the NASs were approved based on a single trial and six cited Phase I or Phase II trials as part of their approvals, indicating that innovative oncology therapiesare moving quickly through R&D and regulatory ling.• Fosnetupitant/palonosetron (Akynzeo) llsanunmetneed to treat acute and delayed nausea and vomiting up to 120 hours after chemotherapy, as an infusion rather than an oral formulation.