Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Sprycel Approved for Children with Ph+ CML

FDA news release; 2017 Nov 9

The FDA has approved Sprycel (dasatinib) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.

Indications: Sprycel is a kinase inhibitor indicated for the treatment of pediatric patients with Ph+ CML in chronic phase.

Dosage and administration: Starting dose is based on body weight. Administer orally, with or without a meal. Do not crush, cut, or chew tablets.

Efficacy and safety: Approval is based on results from 2 trials involving nearly 100 individuals showing that 96% of newly diagnosed patients and 83% of patients resistant or intolerant to imatinib had complete cytogenic response to Sprycel at 24 months.

Side effects/risks: The most common adverse reactions are myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.


FDA approves dasatinib for pediatric patients with CML. [news release]. Silver Spring, MD: FDA. November 9, 2017. Accessed November 13, 2017.

Sprycel [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2017. Accessed November 13, 2017.

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Must Reads in CML

Treatment-free remission in CML, Mahon FX et al. Ann Intern Med. 2018 Feb 20. doi: 10.7326/M17-1094.

Bosulif Approved to Treat Newly-Diagnosed Ph+ CML, Avillion news release; 2017 Dec 19

Sprycel Approved for Children with Ph+ CML, FDA news release; 2017 Nov 9

Be Sure to Consider This When Selecting TKIs, Clin Lymphoma Myeloma Leuk; ePub 2017 Jun 16; Coutinho, et al

FDA Approves Iclusig for Certain Types of CML, ALL, Ariad news release; 2016 Nov 29