Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients aged ≥1 year with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Sprycel, a second generation tyrosine kinase inhibitor, is already approved to treat: Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) in children and adults; chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib in adults; and Ph+ ALL with resistance or intolerance to prior therapy in adults.
The expanded approval was supported by data from the Phase 2 multicenter, single-arm CA180-372 study (NCT01460160) which included 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL. Patients received Sprycel daily for up to 24 months, in combination with chemotherapy (AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol).
The efficacy endpoint was 3-year event-free survival (EFS), defined as the time from the start of Sprycel to lack of complete response at the end of the third high-risk block, relapse, secondary malignancy or death from any cause. Results showed an EFS binary rate of 64.1% (95% CI, 52.4-74.7) at 3 years. The most common serious adverse reactions included pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections, hypersensitivity, vomiting, renal insufficiency, abdominal pain and musculoskeletal pain.
“The Phase 2 CA180-372 trial was particularly informative because it was designed to limit the use of cranial irradiation and stem cell transplant. In the study, Sprycel plus chemotherapy demonstrated a 3-year event-free survival benefit. These results show that Sprycel is an effective medication for physicians to consider for children and adolescents with Ph+ ALL,” stated lead study author Stephen Hunger, MD, chief of the division of oncology and director of the Center for Childhood Cancer Research at Children’s Hospital of Philadelphia.
Sprycel is available as 20mg, 50mg, 70mg, 80mg, 100mg, and 140mg tablets.
For more information call (800) 321-1335 or visit Sprycel.com.