FDA grants fast track designation to zenocutuzumab for neuregulin 1 fusion cancers
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The FDA granted fast track designation to zenocutuzumab for treatment of patients with metastatic solid tumors that harbor neuregulin 1 fusion cancers that progressed on standard therapy.
Zenocutuzumab (Merus) is a bispecific antibody that binds to the HER2 and HER3 receptors.
Neuregulin 1 (NRG1) gene fusions are rare but potentially actionable oncogenic drivers found in some solid tumors, including pancreatic, breast, lung, colorectal and ovarian cancers.
Enrollment is underway for the phase 1/phase 2 eNRGy trial, designed to evaluate zenocutuzumab monotherapy for patients with NRG1-positive malignancies. The three-cohort study will include patients with non-small cell lung cancer, pancreatic cancer and other solid tumors.
“Receiving fast track designation is another important milestone for zenocutuzumab, and it validates the potential for addressing the unmet need of patients with [NRG1-positive] cancers,” Andrew Joe, MD, chief medical officer of Merus, said in a company-issued press release. “We continue to add clinical trial sites to and enroll patients in the eNRGy trial and look forward to providing a substantial clinical program update at a major medical meeting in the second quarter of 2021.”
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