MK-1084

FDA Approves Bizengri for NRG1 Fusion-Positive Lung and Pancreatic Cancers

7 months ago

• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma and non-small cell lung cancer with NRG1 gene fusions. • Bizengri is the first systemic therapy approved by the FDA specifically targeting NRG1 gene fusions in these cancers after prior systemic therapy. • Clinical trial data showed overall response rates of 40% in pancreatic cancer and 33% in NSCLC, with manageable side effects, supporting the approval. • This approval highlights the importance of biomarker testing to identify NRG1 fusions, enabling personalized treatment for these difficult-to-treat cancers.

AstraZeneca's Voydeya Approved for PNH, Merck Advances KRAS Inhibitor

a year ago

• The FDA has approved AstraZeneca's Voydeya (danicopan) as an add-on therapy for extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH). • Merck's oral KRAS G12C inhibitor candidate, MK-1084, has entered phase III development for first-line treatment of metastatic non-small cell lung cancer (NSCLC). • Jazz Pharmaceuticals has completed filing a regulatory application for zanidatamab, targeting HER2-positive metastatic biliary tract cancer (BTC).

FDA Approves Bizengri for NRG1 Fusion-Positive Lung and Pancreatic Cancers

AstraZeneca's Voydeya Approved for PNH, Merck Advances KRAS Inhibitor

Drug Development Updates