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Concentrate for solution for infusion

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Platinum-resistant ovarian cancer (PROC); recurrent/advanced endometrial cancer (EC) Clinical stage: Phase 3. Modality: Biological (FRα-targeted antibody-drug conjugate (ADC) — NBE) Mechanism / Target: Humanised anti-folate receptor alpha (FRα) IgG1 antibody ( conjugated to a topoisomerase I inhibitor payload (camptothecin-based); FRα highly expressed in ovarian and endometrial cancers; ADC delivers cytotoxic payload selectively to FRα-positive tumour cells via receptor-mediated internalisation; bystander killing effect on FRα-negative adjacent cells Route / form: IV infusion (Q3W)
Manufacturer #6964
Europe-based biotechnology company specializing in Rx antibody therapeutics, including approved monoclonal and bispecific antibodies. Portfolio addresses hematological cancers and other indications. Pursues global commercialization through partnerships with major pharmaceutical companies; products are approved across major regulated markets.

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