Merus NV announced that the U.S. FDA has approved a Biologics License Application (BLA) for their bispecific antibody zenocutuzumab (Zeno) to treat patients with non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) harboring neuregulin 1 fusion (NRG1+), granting it priority review.

Medical Officer, emphasized the significance of this milestone for both the company and patients facing NRG1+ cancers.

Zenocutuzumab potentially offers a novel targeted therapy for these cancers, which currently have limited treatment options and a challenging prognosis.

The BLA submission includes comprehensive clinical data, including results from the Phase I/II eNRGy trial evaluating Zeno monotherapy's safety and efficacy in NRG1+ NSCLC, PDAC, and other solid tumors.

These findings were presented at medical conferences such as the American Society of Clinical Oncology (ASCO) Annual Meeting in 2021, with subsequent updates at ASCO 2022 and the European Society for Medical Oncology (ESMO) Congress in 2023.

Additionally, the FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for treating advanced, unresectable, or metastatic NRG1+ pancreatic cancer and NSCLC in patients who have progressed on prior systemic therapy or have no satisfactory alternative treatment options.

It's important to note that while Zeno is in clinical development, its safety and efficacy are still under evaluation by regulatory authorities.





Source: globenewswire.com

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Merus NV announced that the U.S. FDA has approved a Biologics License Application (BLA) for their bispecific antibody zenocutuzumab (Zeno) to treat patients with non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) harboring neuregulin 1 fusion (NRG1+), granting it priority review.

Medical Officer, emphasized the significance of this milestone for both the company and patients facing NRG1+ cancers.

Zenocutuzumab potentially offers a novel targeted therapy for these cancers, which currently have limited treatment options and a challenging prognosis.

The BLA submission includes comprehensive clinical data, including results from the Phase I/II eNRGy trial evaluating Zeno monotherapy's safety and efficacy in NRG1+ NSCLC, PDAC, and other solid tumors.

These findings were presented at medical conferences such as the American Society of Clinical Oncology (ASCO) Annual Meeting in 2021, with subsequent updates at ASCO 2022 and the European Society for Medical Oncology (ESMO) Congress in 2023.

Additionally, the FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for treating advanced, unresectable, or metastatic NRG1+ pancreatic cancer and NSCLC in patients who have progressed on prior systemic therapy or have no satisfactory alternative treatment options.

It's important to note that while Zeno is in clinical development, its safety and efficacy are still under evaluation by regulatory authorities.





Source: globenewswire.com

Report Abuse