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.

This Week's Must Reads

Gene sequencing bone marrow in myelodysplastic syndrome, Duncavage EJ et al. N Engl J Med 2018;379:1028-41.

Levofloxacin prophylaxis in ALL, AML , Alexander S, et al. JAMA. 2018;320(10):995-1004

Genetic markers signal poor prognosis in MCL, Obr A et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 23. doi: 10.1016/j.clml.2018.07.282

Disparities in ALL treatment toxicity, Taylor OA et al. Clin Cancer Res. 2018 Sep 11. doi: 10.1158/1078-0432.CCR-18-0939

Leukemia risk after maternal contraception use, Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0

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