Formosa Pharmaceuticals Files for Clinical Trial of HER2-Positive Breast Cancer Drug
Formosa Pharmaceuticals has submitted a Clinical Trial Application to the U.S. FDA for TSY-110, an antibody-drug conjugate targeting HER2-positive breast cancers.
Formosa Pharmaceuticals has submitted a Clinical Trial Application to the U.S. Food and Drug Administration (FDA) for its new cancer drug candidate, TSY-110. The compound is an antibody-drug conjugate designed to treat HER2-positive breast cancers.
TSY-110 is positioned to become the first biosimilar alternative to Roche's Kadcyla® (ado-trastuzumab emtansine) in major regulated markets. Biosimilars are highly similar to their reference biologic products and are expected to increase competition and potentially lower treatment costs.
The company anticipates that successful clinical trials for TSY-110 could offer a more cost-effective treatment option for patients diagnosed with HER2-positive breast cancer, a condition often requiring complex and expensive therapies.
The submission to the FDA marks the initial step in the drug's approval pathway. Regulatory authorities will now review the application to determine if clinical trials can commence to assess the drug's safety and efficacy in human subjects.