Home/Pipeline/[vic-]trastuzumab duocarmazine (SYD985)

[vic-]trastuzumab duocarmazine (SYD985)

HER2-positive metastatic breast cancer

Phase 3Active (BLA submitted, received CRL)

Key Facts

Indication
HER2-positive metastatic breast cancer
Phase
Phase 3
Status
Active (BLA submitted, received CRL)
Company

About Byondis

Byondis is a clinical-stage biotech developing a proprietary pipeline of antibody-drug conjugates (ADCs) for oncology, anchored by its lead asset, [vic-]trastuzumab duocarmazine (SYD985). The company leverages its internal ADC platform, including its proprietary linker-payload technology (duocarmycin-based), to create targeted therapies. While it faced a significant setback with a Complete Response Letter from the FDA for its lead candidate in HER2-positive metastatic breast cancer, Byondis continues to advance other pipeline programs and explore strategic options, including partnerships or out-licensing, to realize the value of its technology.

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Therapeutic Areas

Other HER2-positive metastatic breast cancer Drugs