Zenocutuzumab (Zeno) Receives Second Breakthrough Therapy Designation from U.S. Food & Drug Administration

Thursday, July 06, 2023

Merus N.V., a clinical-stage oncology company focused on developing innovative antibodies for cancer treatment, recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for their drug, zenocutuzumab (Zeno). This designation specifically recognizes Zeno's potential in treating advanced unresectable or metastatic NRG1 fusion (NRG1+) non-small cell lung cancer (NSCLC) in patients who have experienced disease progression after prior systemic therapy.

The BTD for Zeno is based on promising data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP). These programs aim to evaluate the safety and effectiveness of Zeno as a monotherapy for NRG1+ cancer. Notably, over 175 patients with NRG1+ cancer have received Zeno monotherapy thus far.

Breakthrough Therapy Designation is granted to therapies that exhibit substantial potential in improving treatment outcomes for serious or life-threatening conditions compared to existing therapies. It streamlines the development and review process, enabling closer guidance from the FDA, and making the treatment eligible for rolling and priority review.

Merus plans to engage in discussions with the FDA to expedite the development of Zeno and provide further updates regarding the timeline for potential submission of a Biologics License Application (BLA). The company emphasizes the significance of establishing a commercialization partnership to ensure broad access to Zeno for patients with NRG1+ cancer, if it receives approval. Furthermore, Merus intends to present a comprehensive clinical update on Zeno for NRG1+ cancer at a major medical conference in 2023.

In addition to NRG1+ lung cancer, Merus is also investigating the use of Zeno in combination with androgen deprivation therapy in castration-resistant prostate cancer (CRPC), regardless of NRG1+ status. Preliminary clinical data on Zeno in CRPC is anticipated to be released in the latter half of 2023. The company is also exploring the combination of Zeno with afatinib for the treatment of NRG1+ NSCLC patients.

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