Thanks to a Phase 2 trial, pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia or Ph+ ALL, now have a new treatment option. The FDA has announced approval of Sprycel (dasatinib) for use in combination with chemotherapy in patients who are younger than age 18. This approval may reduce the need of stem cell transplants for some patients.
The trial which brought approval
The Phase 2 trial was titled CA180-372. There were 106 participants, all newly diagnosed with Ph+ ALL who were under the age of 18. Each patient received Sprycel each day, starting on day 15 of chemotherapy. Cohort one of the study involved 78 patients who were each given 60 mg/m2 of the drug each day for two years. During this time they also received chemotherapy. All patients in cohort one of the study achieved complete remission.
Those in this study who were considered high-risk due to detection of minimal residual disease also became eligible for a stem cell transplant. 15 patients of the 106 ended up receiving a transplant. However, this study is significant because Sprycel was able to eliminate the need of transplantation for so many of the involved patients.
This drug has already shown efficacy and has been approved for those diagnosed with chronic myeloid leukemia. In fact adult chronic myeloid leukemia patients given Sprycel achieved remission faster than those given imatinib. The hope, and the expectation, is that Sprycel will have an even stronger effect against Ph+ ALL for pediatric patients. A randomized study will hopefully be performed soon to continue to investigate this drugs potential.
Researchers are excited about this new discovery and the drugs approval. However, they do admit more research is still needed to fully assure the value of this drug for pediatric Ph+ ALL patients.
you can read more about this research and the study which led to Sprycel’s approval here.