Metastatic breast cancer in pleural fluid. Credit: Ed Uthman/Flickr.

Netherlands-based Synthon Biopharmaceuticals has obtained fast-track designation from the US Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) to treat HER2-positive metastatic breast cancer (MBC).

The approval covers patients whose disease has progressed during or following a minimum of two HER2-targeting regimens for locally advanced or metastatic disease, or progressed during or after treatment with [ado-]trastuzumab emtansine.

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SYD985 received the designation based on the positive results obtained during its two-part Phase I clinical trial (SYD985.001) in heavily pre-treated last-line HER2-positive MBC patients.

This trial investigated the safety, pharmacokinetics and efficacy of the drug candidate in such patients who had histologically confirmed, locally advanced or metastatic tumours.

“There is a high unmet medical need in patients that have HER2-positive MBC and have progressed on trastuzumab and [ado-]trastuzumab emtansine.”

Synthon Biopharmaceuticals CEO Jacques Lemmens said: “There is a high unmet medical need in patients that have HER2-positive MBC and have progressed on trastuzumab and [ado-]trastuzumab emtansine.

“I believe that the benefit / risk balance of [vic-]trastuzumab duocarmazine is favourable and that it can provide extended benefit to these patients.

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“Fast-track designation will support efficient development and review of [vic-]trastuzumab duocarmazine and enable early access of this promising new single-agent therapy option.”

The efficacy and safety of SYD985 are being further investigated in a multi-centre, open-label, randomised Phase III trial (SYD985.002 or TULIP) with HER2-positive unresectable locally advanced or MBC patients at 100 clinical sites in the US, Canada, Europe and Singapore.

The trial’s primary objective is to establish the superiority of SYD985 over physicians’ choice of extending progression-free survival (PFS).