Merus’ Zenocutuzumab Receives the US FDA’s Breakthrough Therapy Designation for NRG1 Fusion Non-Small Cell Lung Cancer
Shots:
- The US FDA has granted BTD to zenocutuzumab for advanced unresectable or metastatic NRG1 fusion (NRG1+) NSCLC, following progression with prior systemic therapy
- The BTD was based on an ongoing P-I/II trial (eNRGy) and Early Access Program evaluating zenocutuzumab monotx. in NRG1+ cancer. In the (eNRGy) trial, investigator-assessed ORR (34%) after a median follow-up of 6.3mos. among all evaluable patients, the median time to response was 1.8mos., and m-DoR was 9.1mos., any-grade TRAEs (61%) incl. grade 3/4 TRAEs in 5%
- The company plans to provide a clinical update on zenocutuzumab in NRG1+ cancer at a major medical conference in 2023 & is expected to provide initial clinical data on zenocutuzumab in H2’23 for CRPC
Ref: Globenewswire | Image: Merus
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
