Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma
Shots:
- The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion
- sBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in the cholangiocarcinoma cohort
- Based on these data, NCCN added Bizengri to guidelines for biliary tract cancers as Category 2A subsequent therapy & Category 2B frontline option for NRG1 fusion–positive cholangiocarcinoma
Ref: PRnewswire | Image: Partner |Press Release
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