NEW YORK – The US Food and Drug Administration on Wednesday granted accelerated approval to Merus' Bizengri (zenocutuzumab) for advanced non-small cell lung cancer patients and advanced pancreatic cancer patients whose tumors harbor NRG1 gene fusions.
"This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion," the agency said in a statement.
The agency approved Bizengri, which is designed to inhibit the neuregulin/HER3 tumor-signaling pathway, based on results from the Phase II eNRGy study. The trial included 64 NRG1 fusion-positive NSCLC patients and 30 NRG1 fusion-positive pancreatic cancer patients, all of whom had received prior treatment with standard of care.
Among NSCLC patients, the overall response rate was 33 percent and the median duration of response was 7.4 months. Among the pancreatic cancer patients, the overall response rate was 40 percent and the duration of response ranged from 3.7 months to 16.6 months.
In August, Merus, based in Utrecht, Netherlands, inked a partnership with Roche subsidiary Foundation Medicine, under which Foundation agreed to develop its RNA platform as a companion diagnostic for Bizengri.