Dublin, Ireland-based Jazz Pharmaceuticals’ Vyxeos is being given a speedy review in Europe as a treatment for certain types of high-risk acute myeloid leukemia (AML).
The European Medicines Agency’s Committee for Medicinal Products for Human Use is considering the chemotherapy’s use treat adults with high-risk AML defined as therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Vyxeos (daunorubicin and cytarabine) has also been awarded Promising Innovative Medicine (PIM) designation from the UK’s Medicines and Healthcare
Products Regulatory Agency, an early indication that it is a potential candidate for the Early Access to Medicines Scheme (EAMS), which is designed to accelerate access to novel therapies where there is unmet medical need.
“If approved, Vyxeos will become the first new chemotherapy treatment option specifically for European patients with therapy-related AML or AML with myelodysplasia-related changes,” said Karen Smith, executive vice president, research and development and chief medical officer at Jazz.
“We are passionate about bringing a new treatment option for high-risk AML to the appropriate patients in the EU as quickly as possible and look forward to working with the CHMP during this review process.”