(Reuters) -The U.S. Food and Drug Administration on Tuesday extended the review of Merus NV’s gene-targeting cancer therapy to allow sufficient time to review some recent information submitted by the company.
The agency will now decide on the treatment by Feb. 4 2025, compared to a previous action date of Nov. 6.
Merus said the newly submitted data was in response to a Chemistry, Manufacturing, and Control (CMC) information request, which details the manufacturing process, quality control, and analytical methods used to produce therapies.
The FDA has not requested any additional clinical data, it said.
Merus’ cancer therapy, zenocutuzumab, targets the NRG1 gene, which is associated with the formation and progression of several tumors.
The company is seeking approval for the therapy in patients with hard-to-treat types of lung and pancreatic cancers who have NRG1 fusions.
Merus said that obtaining a commercialization partnership agreement is an important step in bringing zeno to patients with NRG1+ cancer if approved.
(Reporting by Bhanvi Satija and Christy Santhosh in Bengaluru; Editing by Abinaya Vijayaraghavan)
