Lindis Biotech’ Korjuny (Catumaxomab) Receives the CHMP’s Positive Opinion to Treat Malignant Ascites (MA)
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The CHMP has granted a positive opinion to Korjuny (trifunctional anti-CD3 x anti-EpCAM Ab) for treating malignant ascites in adults with EpCAM+ carcinomas, not eligible for systemic anti-cancer treatment. EC’s decision is anticipated by YE’24, & will be valid in the EU plus Norway, Iceland & Liechtenstein
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The opinion was based on P-II/III (IP-REM-AC-01) study showing four-fold increase in the 1EP of puncture-free survival vs therapy with only puncture treatment
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Moreover, recruitment for the P-I (CATUNIBLA) dose escalation & expansion study for high and intermediate-risk non-muscle invasive bladder cancer (HR-NMIBC) has been completed. Interim readouts were highlighted at the ESMO 2024
Ref: Lindis Biotech | Image: Lindis Biotech
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com