FDA Delays Decision on Merus’ Zenocutuzumab for NRG1+ Lung and Pancreatic Cancer

FDA Review Extension:
The FDA has extended the review period for Merus' bispecific antibody zenocutuzumab, which is being developed for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC).

New PDUFA Date:
The new Prescription Drug User Fee Act (PDUFA) date is February 4, 2025, following a three-month extension from the original date of November 4, 2024.

Reason for Delay:
The delay is to allow sufficient time for the FDA to review additional Chemistry, Manufacturing, and Controls (CMC) information submitted by Merus in response to a previous request. No additional clinical efficacy or safety data were requested.

Potential Impact:
Despite the delay, analysts such as Asthika Goonewardene from Truist Securities believe that an approval is still expected and that the delay is not a cause for concern.

Clinical Data:
Zenocutuzumab has shown promising results in clinical trials, including a 44% confirmed objective response rate in patients with NRG1+ PDAC and a 37% objective response rate in NSCLC patients with NRG1 fusions.

Regulatory Status:
Zenocutuzumab has been granted Priority Review, Breakthrough Therapy Designation, and Fast Track Designation by the FDA for its potential in treating NRG1+ cancers.