![THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS ISSUED A COMPLETE RESPONSE LETTER CONCERNING [VIC-]TRASTUZUMAB DUOCARMAZINE, A PRODUCT DEVELOPED BY BYONDIS.](https://pharmtales.com/wp-content/uploads/2023/06/FDA-Issues-Response-Letter-on-Byondis-Trastuzumab-Duocarmazine-1024x683.jpg)
Byondis B.V., a Dutch clinical-stage biopharmaceutical company specializing in precision medicines, has announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). This ADC, an anti-HER2 antibody-drug conjugate, was seeking approval for the treatment of HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), a condition with significant unmet medical needs.
The FDA’s complete response letter indicates a suspension of the decision on the product’s approvability. The agency has requested additional information that goes beyond the current evaluation period and requires additional time and resources.
Despite this outcome, Byondis remains optimistic about the potential of SYD985. “We firmly believe that SYD985 can provide a meaningful treatment option for patients living with HER2-positive metastatic breast cancer,” stated Byondis CEO Marco Timmers, Ph.D. “We appreciate the FDA’s guidance and support and will thoroughly evaluate the complete response letter to determine our next steps.”
Timmers further added, “We will continue with the applications for SYD985 in the EU and UK and await the results of the review process.”
The BLA and Marketing Authorization Application (MAA) for [vic-]trastuzumab duocarmazine are supported by data from the Phase III TULIP study, a pivotal multi-center, open-label, randomized clinical trial. This study compared SYD985 to physician’s choice (PC) treatment in pre-treated patients with HER2-positive unresectable locally advanced or metastatic breast cancer (SYD985.002/NCT03262935). The TULIP study, whose results were presented at the 2021 ESMO Congress, successfully met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement of 2.1 months over PC. Additionally, TULIP showed encouraging overall survival (OS) results.
