FDA Names New Drug Tarextumab "Orphan Drug" for Small Cell Lung Cancer

The gist: The U.S. Food and Drug Administration (FDA) has granted “orphan drug” designation to a new drug called tarextumab for small cell lung cancer (SCLC) and pancreatic cancer. The designation will make it easier for the drug maker to successfully develop tarextumab and get it to patients in the U.S. Tarextumab has shown promise in patients in a clinical trial. It is given to patients in combination with chemotherapy.

“The US Food and Drug Administration (FDA) has granted orphan drug designation to the OncoMed agent tarextumab for the treatment of pancreatic cancer and lung cancer. Tarextumab (formerly OMP-59R5) is a fully human monoclonal antibody targeting the Notch 2/3 receptors.

“ ‘We are excited to receive two separate orphan drug designations for tarextumab for the treatment of pancreatic and small-cell lung cancer,’ said Paul J. Hastings, OncoMed’s chairman and chief executive officer, in a statement.

“Earlier this month the drug company announced final phase 1b clinical and biomarker data from the ALPINE (Antibody Therapy in First-Line Pancreatic Cancer Investigating Anti-Notch Efficacy and Safety) study, which tested tarextumab in combination with gemcitabine plus nab-paclitaxel in pancreatic cancer.

“Of the 29 patients in the trial, 21 (73%) achieved either a partial response or stable disease with the combination therapy.”