{"id":16907,"date":"2024-12-05T20:48:34","date_gmt":"2024-12-05T12:48:34","guid":{"rendered":"https:\/\/flcube.com\/?p=16907"},"modified":"2024-12-05T20:48:37","modified_gmt":"2024-12-05T12:48:37","slug":"merus-n-v-receives-fda-approval-for-bizengri-for-nrg1-pancreatic-and-lung-cancers","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=16907","title":{"rendered":"Merus N.V. Receives FDA Approval for Bizengri for NRG1+ Pancreatic and Lung Cancers"},"content":{"rendered":"\n

Holland-based Merus N.V. (NASDAQ: MRUS<\/a>) has announced that it has received FDA approval for its bispecific antibody (BsAb), Bizengri (zenocutuzumab-zbco), targeting HER2 and HER3 for the treatment of adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are advanced, unresectable, or metastatic and harbor a neuregulin 1 (NRG1) gene fusion. These patients must have experienced disease progression on or after prior systemic therapy.<\/p>\n\n\n\n

Positive Results from the eNRGy Trial<\/strong>
The FDA’s endorsement is supported by positive results from the eNRGy trial, which demonstrated an objective response rate (ORR) of 40% (95% CI, 23%-59%) and a duration of response (DOR) of 16.6 months in 30 patients with NRG1+ pancreatic adenocarcinoma treated with zenocutuzumab. In the same trial, 64 patients with NRG1+ NSCLC treated with the drug showed an ORR of 33% (95% CI, 22%-46%) and a median DOR of 7.4 months (95% CI, 4.0-16.6). The drug’s safety and tolerability were also confirmed in the study.<\/p>\n\n\n\n

Commercialization Rights and Partnership<\/strong>
Previously, Merus out-licensed the commercialization rights to Bizengri in the US to Partner Therapeutics, a strategic move to expand the drug’s reach and ensure its availability to patients in need.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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