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. 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.
This Week's Must Reads
Gene therapy in severe hemophilia B, Reiss UM et al. ASH 2018, Abstract 491
Luspatercept reduced transfusion burden in trial, List AF et al. ASH 2018, abstract 1
Consider bleeding disorders in heavy menstrual bleeding, O’Brien B et al. J Pediatr Adolesc Gynecol. 2018 Nov 22 . doi: 10.1016/j.jpag.2018.11.005
Lower-dose treatment could save money in aTTP, Zwicker JI et al. ASH 2018, Abstract 374
Low rates of bleeding with DOAC interruption, Douketis J et al. ASH 2018, Abstract LBA-5
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