The U.S. Food and Drug Administration (FDA) has approved trastuzumab-strf, a biosimilar of trastuzumab, for the treatment of HER2-overexpressing breast cancer and adenocarcinoma of the stomach or gastroesophageal junction. Indications: Trastuzumab-strf is indicated for: Adjuvant therapy for HER2-overexpressing breast cancer; Treatment of HER2-overexpressing metastatic breast cancer; Treatment of HER2-overexpressing metastatic adenocarcinoma of the stomach or gastroesophageal junction. HER2-positive cancers are typically highly aggressive malignancies but respond well to targeted therapy. Trastuzumab-strf works by binding to and inhibiting the HER2 receptor, thereby slowing cancer cell replication.
Approval Basis
FDA approval is based on a series of analyses, preclinical, and clinical data demonstrating that trastuzumab-strf is highly similar to its reference drug (trastuzumab, Herceptin) in terms of efficacy, safety, and quality. Since 2015, the clinical trial program for trastuzumab-strf has included three studies to verify its comparability with the reference drug in pharmacokinetics and clinical efficacy/safety.
Clinical Study Overview
Two Phase I single-dose pharmacokinetic equivalence studies (HLX02-HV01 and HLX02-HV02): conducted in healthy volunteers.
One supportive Phase III double-blind randomized clinical trial (HLX02-BC01): in patients with HER2-overexpressing metastatic breast cancer, evaluating efficacy and safety in combination with docetaxel.
Data from HLX02-HV02 and HLX02-BC01 comply with current FDA guidelines for biosimilars, demonstrating no clinically significant differences between trastuzumab-strf and the reference drug, supporting their biosimilarity.
Safety
The safety profile of trastuzumab-strf is consistent with that of the reference drug, trastuzumab, with study data showing no significant clinical differences in the subjects.
Dosage and Future Development
The FDA-approved dosage of trastuzumab-strf is 150 mg. A 420 mg dosage form is under development, with FDA approval expected later in 2024.
Disclaimer
This article has not been reviewed by the American Society of Clinical Oncology (ASCO®) and does not necessarily reflect the views and opinions of ASCO®.
Source: https://ascopost.com/news/april-2024/fda-approves-trastuzumab-biosimilar-trastuzumab-strf/