FDA accepts Byondis’ Biologics License Application for breast cancer treatment

The FDA has accepted Byondis’ submission of a Biologics License Application (BLA) for [vic-] trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable, locally advanced or metastatic breast cancer (MBC).

SYD985 is an investigational next generation anti-HER2 antibody-drug conjugate (ADC) which was granted fast track designation by the FDA in January 2018, based on promising Phase I data involving heavily pretreated last-line HER2-positive MBC patients.

The antibody part of trastuzumab duocarmazine binds to HER2 on the surface of the cancer cell, and the ADC is internalised by the cell. After proteolytic cleavage of the linker, the inactive cytotoxin is activated, and DNA damage is induced, resulting in tumour cell death. SYD985 is considered a form of targeted therapy.

With HER2-positive breast cancer, overexpression of the human epidermal growth factor receptor 2 (HER2) protein causes out-of-control reproduction of breast cells. Less than 20 percent of all breast cancers are HER2-positive, and younger women are the most affected.

“Women with HER2-positive breast cancer generally have a more aggressive disease, greater likelihood of recurrence and poorer prognosis,” said Byondis CMO Jan Schellens, MD, PhD. “Today’s SYD985 BLA acceptance by the FDA is an important step forward toward our goal of providing a much-needed alternative for these patients.”

“With our proprietary technologies, we aim to offer antibody-drug conjugates with a novel mechanism-of-action, which are still efficacious when other ADC therapies have been exhausted,” said Byondis CEO Marco Timmers, PhD. “SYD985 combines a HER2-targeting antibody with a novel and potent cytotoxic drug in a way that limits damage to healthy tissue.”

Lina Adams