FDA approves zenocutuzumab for previously treated NRG1-fusion cholangiocarcinoma

The FDA has granted approval for zenocutuzumab to treat patients with previously treated, advanced cholangiocarcinoma that carries an NRG1 fusion. The decision was based on data from the eNRGy study, which showed an objective response rate of 36.8%.

Key safety concerns highlighted include infusion-related reactions, interstitial lung disease or pneumonitis, and potential left-ventricular dysfunction. Clinicians will need to monitor patients for these events during therapy.

In related news, the agency also accepted a supplemental NDA for taletrectinib targeting ROS1-positive non-small cell lung cancer, citing high response rates and durable disease control, with confirmatory trials ongoing.