The FDA has approved a new indication for dasatinib (Sprycel) as a treatment for Philadelphia chromosome positive (Ph+) chronic phase chronic myeloid leukemia (CML), when it is first diagnosed.
In June 2006, dasatinib was granted accelerated approval to treat adults with chronic phase CML who had resistant disease or were unable to tolerate prior therapy. Dasatinib was converted to a regular approval in May 2009, after 24-month follow-up data from earlier clinical studies confirmed the agent's safety and efficacy.
This is the third drug approved for Ph+ chronic phase CML under accelerated approval (imatinib approved in May 2001 and nilotinib approved in October 2007). One open-label, randomized clinical trial in patients with chronic phase CML evaluated the safety and effectiveness of dasatinib, measuring complete cytogenetic response and cytogenetic response.
The most commonly reported side effects included myelosuppression, fluid retention, diarrhea, headache, musculoskeletal pain, and rash.
“These drugs have dramatically changed the lives of patients with CML,” Richard Pazdur, MD, Director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.
“Results from additional CML studies continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease.”