Shots:
- The US FDA has granted accelerated approval to Bizengri for the treatment of advanced, unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC. It will be commercialized by Partner Therapeutics in the US under previously signed agreement
- Approval was based on eNRGy study assessing the safety, tolerability, PK/PD, immunogenicity & anti-tumor activity of zenocutuzumab to treat NRG1+ solid tumors incl. pancreatic cancer (n=30) & NSCLC (n=64) in patients, progressed on prior treatment
- Study demonstrated an ORR of 40% & DoR range from 3.7 to 16.6mos. in pancreatic cancer patients while ORR of 33% & mDoR of 7.4mos. in NSCLC patients
Ref: GlobeNewswire | Image: Merus | Press Release
Related News:- BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM
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