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.

Citation:

FDA approves dasatinib for pediatric patients with CML. [news release]. Silver Spring, MD: FDA. November 9, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm584725.htm.... Accessed November 13, 2017.

Sprycel [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2017. https://packageinserts.bms.com/pi/pi_sprycel.pdf. Accessed November 13, 2017.

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