The approval is the first for a treatment designed for cancers with an NRG1 gene fusion. The treatment is for patients with non-small cell lung cancer and pancreatic cancer that has spread and no longer responds to treatment.
The approval came after positive results from a clinical trial that included 64 adults with NRG1 fusion-positive non-small cell lung cancer and 30 adults with NRG1 fusion-positive pancreatic adenocarcinoma. In the trial, about one-third of lung cancer patients and 40% of pancreatic cancer patients showed a response to treatment.
The treatment does have potential side effects, including diarrhea, pain in muscle and bones, fatigue, nausea and reactions to the infusion.
