Bristol-Myers Squibb Co. said the U.S. Food and Drug Administration approved a combination of its cancer drug Sprycel and chemotherapy to treat certain children with a type of blood cancer.
Philadelphia chromosome-positive acute lymphoblastic leukemia, or Ph+ ALL, is a rare subtype of acute lymphoblastic leukemia. In Ph+ ALL, patients have a chromosome alteration that causes the BCR-ABL gene to mutate and produce a protein that leads to the growth and reproduction of cancer cells.
Sprycel, or dasatinib, is now approved to treat children one year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
The approval, which was granted after priority review by the FDA, is based on data from a phase 2 study in 78 patients with showed that event-free survival, the length of time after start of Sprycel treatment to lack of remission or certain complications including death, was 64.1% after three years.
Sprycel is already approved to treat children with Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML, in chronic phase.
The drug is also approved to treat adult patients with Ph+ CML in chronic phase; with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and with Ph+ ALL with resistance or intolerance to prior therapy.