The US Food and Drug Administration has approved a new treatment for children one year of age and older, facing a type of blood cancer known as Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) when used in combination with chemotherapy.
Bristol-Myers Squibb announced that the approval, which was granted following priority review by the FDA, is based on data from the Phase II study, CA180-372 (NCT01460160).
The study consisted of 78 patients evaluated for efficacy for up to 24 months, when the drug was used in combination with chemotherapy. The study showed that Sprycel in combination with chemotherapy showed a three-year event-free survival benefit in Ph+ ALL.
ALL is the most common childhood cancer in the US, representing 20% of all cancers diagnosed in persons aged less than 20 years, with more than 3,000 new cases each year.
“We recognise the urgency around developing and delivering therapies for children and young adults living with cancer, and today’s approval is an important example of our commitment to pediatric oncology,” commented Jeffrey Jackson, Ph.D., development lead, hematology, Bristol-Myers Squibb.”
He continued, “Building on our previous indication for children with Ph+ chronic myeloid leukemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL.”