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# Byondis BLA for Breast Cancer Therapy Accepted
- URL: https://www.fdaweb.com/byondis-bla-for-breast-cancer-therapy-accepted/
- Published: 2022-07-12T12:00:00.000Z
- Updated: 2026-09-14T17:51:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152258

FDA has accepted for review a Byondis BLA for SYD985 (\[Vic-\] trastuzumab duocarmazine) for use in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The agency has set a user fee review action target date of 5/12/2023.

The submission is based on data from the pivotal Phase 3 TULIP multi-center, open-label, randomized clinical trial comparing SYD985 to physician’s choice (PC) treatment in patients with pre-treated HER2-positive unresectable locally advanced or metastatic breast cancer, according to the company. The study met its primary endpoint of progression-free survival, showing a statistically significant improvement of 2.1 months over PC. It also “demonstrated supportive overall survival results,” Byondis says.

The company describes SYD985 as an investigational next generation anti-HER2 antibody-drug conjugate that was granted fast track designation in 2018 based on promising Phase1I data involving heavily pretreated last-line HER2-positive MBC patients. “SYD985 combines a HER2-targeting antibody with a novel and potent cytotoxic drug in a way that limits damage to healthy tissue,” it says.