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EMA validates application for Byondis’ trastuzumab duocarmazine

The submission follows positive results of phase 3 trial focusing on breast cancer therapy

Byondis has announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for the company’s investigational next generation anti-HER2 antibody-drug conjugate.

Trastuzumab duocarmazine – also known as SYD985 – targets patients with HER2-positive unresectable locally advanced or metastatic breast cancer.

If it is granted the marketing authorisation applies to all EU member states, as well the European Economic Area countries, including Iceland, Liechtenstein and Norway. The treatment will be marketed by Byondis’ commercialisation partner and marketing authorisation applicant Medac, a privately owned pharmaceutical company based in Germany.

Medac has an exclusive license to conduct marketing in all approved indications across the EU, UK and other European countries.

The MAA is supported by data from Byondis’ pivotal phase 3 TULIP trial – a multi-centre, open-label, randomised clinical study comparing SYD985 to the physician’s choice treatment in patients with pre-treated HER2-positive unresectable locally advanced or metastatic breast cancer.

The study met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement of over months, while TULIP also demonstrated supportive overall survival results.

“The MAA validation is an important step forward in our mission to make hope real for patients,” explained Byondis chief executive officer Marco Timmers. “About one in five breast cancers are HER2-positive, often resulting in a more aggressive disease. There is a dire need to provide an alternative treatment option to these patients.”

“Medac shares Byondis’ passion for delivering tolerable, more effective cancer treatment options,” added medac managing director and chief executive officer Jörg Hans. “This important milestone brings us closer to realising this goal.”

Byondis is an independent, Dutch clinical stage biopharmaceutical company which concentrates on developing precision medicines.