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(Sharecast News) - European regulators have validated two marketing authorisation applications (MMAs) for AstraZeneca, as the biopharma giant's datopotamab deruxtecan chemotherapy replacement treatment comes one step closer to receiving the green light to treat two types of cancer.
The validations confirm the completion of the applications and will kickstart the scientific review process of datopotamab deruxtecan by the European Medicines Agency's Committee for Medicinal Products for Human Use.
The first MMA is for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who require systemic therapy following prior treatment. The other is for the treatment of unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer in patients who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy.
Datopotamab deruxtecan, otherwise known as Dato-DXd, is a type of antibody drug conjugate discovered by Japanese pharma group Daiichi Sankyo but is being joint developed by the two companies, after entering into a global collaboration agreement to develop and commercialise the treatment in 2020.
"Today's dual validation of our applications in lung and breast cancers brings this potential medicine a meaningful step closer to redefining treatment expectations for patients with two of the most common cancers in Europe," said Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca.
"Our ambition is for datopotamab deruxtecan to improve upon and replace conventional chemotherapy in the treatment of multiple cancer types."
