FDA grants Zenotuzumab 'fast track qualification' to treat NRG1 gene fusion tumors

NRG1 (Neuroregulin1, Neuromodulation Protein 1) fusion is a rare cancer-causing drive gene that is used as a potential driver of tumor occurrence and growth in a variety of types of solid tumors, including lung, breast, pancreatic, ovarian and colorectal cancers.
although the rate of NRG1 gene fusion is extremely low, NRG1 has a large number of fusion partners, so drug development can be made for this new target.
The U.S. Food and Drug Administration (FDA) has granted Zeno "fast-track eligibility" to treat patients with metastasis solid tumors with NRG1 gene fusion, the company announced today.
Merus is currently recruiting patients for Phase I/II clinical trials aimed at evaluating the effectiveness of Zenocutuzumab's single-drug treatment of pancreatic cancer and other solid tumors that are fusion of the NRG1 gene.
," said Andrew Joe, M.D., chief medical officer at Melus, "The fast-track designation is another milestone for Zenocutuzumab.
We look forward to providing substantive clinical trial data at a major medical conference in the second quarter of 2021."