European Medicines Agency validates Byondis’ trastuzumab duocarmazine application

Moreover, this validation has been given on the basis of the 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.

European Medicines Agency validates Byondis’ trastuzumab duocarmazine application
The net sales rose to Rs 2,292 crore in the first quarter against Rs 2,120 crore in the year-ago period, Torrent Pharma said in a statement. (File)

Byondis on Monday announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for the company’s investigational anti-HER2 antibody-drug conjugate. The company claims that trastuzumab duocarmazine – also known as SYD985 – targets patients with HER2-positive unresectable locally advanced or metastatic breast cancer.

According to reports, if the drug is granted the marketing authorisation, it applies to all EU member states, as well the European Economic Area countries, including Iceland, Liechtenstein and Norway.

Reportedly, the treatment will be marketed by Byondis’ commercialisation partner and marketing authorisation applicant Medac, a privately owned pharmaceutical company based in Germany. Meanwhile, Medac has an exclusive license to conduct marketing in all approved indications across the EU, UK and other European countries.

Moreover, this validation has been given on the basis of the 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 MAA validation is an important step forward in our mission to make hope real for patients. 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 chief executive officer Marco Timmers said in a statement.

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