Baxalta Gets Positive CHMP Opinion For ONCASPAR - Quick Facts

(RTTNews) - Baxalta Inc.(BXLT) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for use of ONCASPAR as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.

The CHMP's positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. Pending EC approval, Baxalta will be authorized to market ONCASPAR in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

ONCASPAR is recommended for marketing authorization in paediatric and adult populations pending a decision anticipated by the European Commission in early 2016.

Pending EC approval, ONCASPAR will provide an important treatment option for more European patients with this rapidly progressing cancer of the white blood cells responsible for more than 80 percent of childhood leukaemia cases - the most common type of childhood cancer.

Acute lymphoblastic leukaemia (ALL) is a rare, fast-growing cancer of the white blood cells, and each year there are approximately 4,000-5,000 new cases in Europe and the United States, respectively. The disease is the most common childhood cancer and is responsible for more than 80 percent of childhood leukaemia cases. The five-year paediatric survival rate has climbed to 90 percent with modern therapies.