FDA accepts priority review for Merus Zeno BLA for NRG1+ NSCLC, PDAC treatment

Merus announced that the U.S. Food and Drug Administration or FDA has accepted for priority review a Biologics License Application or BLA for the bispecific antibody zenocutuzumab, Zeno, in patients with neuregulin 1 fusion or NRG1+ non-small cell lung NSCLC and NRG1+ pancreatic PDAC cancer. “FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies.” The FDA has granted Breakthrough Therapy Designation or BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy.