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Sprycel Approved for Type of Newly Diagnosed Pediatric Leukemia

First and Only Second-Generation TKI for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

The FDA has approved dasatinib (Sprycel, Bristol-Myers Squibb) in combination with chemotherapy for pediatric patients who have newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

Approval was based in part on data from an ongoing phase 2 clinical trial with dasatinib in combination with chemotherapy, in pediatric patients who have newly diagnosed Ph+ ALL.

Dasatinib was continually administered to 106 patients aged <18 years old starting at trial day 15 of induction chemotherapy. Cohort 1 evaluated efficacy in 78 patients treated with dasatinib 60 mg/m2 daily for up to two years in combination with a backbone chemotherapy regimen of the AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol. Patients considered high-risk, based on minimal residual disease (MRD), also received stem cell transplants.

Results showed that all patients achieved complete remission. Those with MRD ≥ 0.05% at day 78 were eligible for hematopoietic stem cell transplantation (HSCT) in first remission.

The most common adverse reactions included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. Serious adverse reactions involved pleural effusion (10%).

Dasatinib was first approved in 2017 for the treatment of pediatric patients with Ph+ chronic myeloid leukemia.

Source:, January 2, 2019

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