FDA Approves Dasatinib for Pediatric Philadelphia Chromosome-positive CML
The FDA based its approval on results from 2 ongoing clinical studies: the open-label, prospective CA180-226 phase 2 trial, and the dose-ranging CA180-018 phase 1 trial.
The US Food and Drug Administration (FDA) has approved dasatinib for pediatric patients with chronic phase (CP) Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML), according to a press release.1
The FDA based its approval on results from 2 ongoing clinical studies: the open-label, prospective CA180-226 (ClinicalTrials.gov Identifier: NCT00777036) phase 2 trial, and the dose-ranging CA180-018 (ClinicalTrials.gov Identifier: NCT00306202) phase 1 trial.
Ninety-seven pediatric patients with CP CML treated with dasatinib were evaluated from both trials; 51 patients from the phase 2 study had newly diagnosed disease, and 46 patients in total from both studies had disease resistant or intolerant (R/I) to imatinib.
Results showed that 96.1% (95% CI, 86.5%-99.5%) and 82.6% (95% CI, 68.6%-92.2%) of patients with newly diagnosed disease and patients with R/I disease, respectively, had a complete cytogenic response (CCyR).
The median durations of CCyR, major molecular response (MMR), and major cytogenic response (MCyR) could not be evaluated at the median follow-up time of 4.5 years for newly diagnosed patients and were 5.2 years for patients with R/I disease. More than half of the patients who had a response did not have progressive disease at the time of data cut-off.
The most frequently reported adverse events occurring in more than 10% of patients were nausea, vomiting, diarrhea, abdominal pain, skin rash, headache, fatigue, arthralgia, and extremity pain.
- FDA approves dasatinib for pediatric patients with CML [news release]. Silver Springs, MD: US Food and Drug Administration; November 9, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm584725.htm?utm_campaign=Oncology%2011%2F13&utm_medium=email&utm_source=Eloqua&elqTrackId=e3fc8b51cc174a8eaf2296d2df9e04e1&elq=66a053c4a4fc440fac81f37231ac87d7&elqaid=1301&elqat=1&elqCampaignId=784. Accessed November 13, 2017.