FDA Approves Labeling Update for Dasatinib

The FDA approved an update to the product labeling for dasatinib (Sprycel), Bristol-Myers Squibb Company and Otsuka America Pharmaceutical announced on June 20.

The updated labeling includes three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as five-year data in patients with Ph+ CML in chronic phase who are resistant or intolerant to imatinib mesylate (Gleevec).

“Bristol-Myers Squibb remains committed to helping patients with newly diagnosed and imatinib-resistant or intolerant chronic phase Ph+ CML through treatment with Sprycel, a convenient once-daily treatment option,” Laura Bessen, MD, vice president and head of US Medical, Bristol-Myers Squibb, said in a statement.

Dasatinib is a kinase inhibitor indicated for the treatment of adults with newly diagnosed chronic phase Ph+ CML. Since its approval in 2006, more than 175,000 prescriptions for dasatinib have been written, Bessen noted.

Information added to the dasatinib label in the first-line chronic phase Ph+ CML setting is based on three-year data from the DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CML Patients) trial, the companies stated. In the open-label, phase III trial, 519 patients were randomized to 100 mg of once-daily dasatinib or 400 mg of once-daily imatinib. Dasatinib demonstrated superior efficacy to imatinib as defined by higher molecular (major molecular response) and confirmed cytogenetic response rates by 12 months.

Greg Stephens

Information added to the dasatinib label for chronic-phase Ph+ CML patients resistant or intolerant to imatinib is based on data from the CA180-034 study, according to the companies. In the phase III, open-label, dose-optimization trial, 670 patients with CML were randomized to receive dasatinib at doses of 100 mg once daily (n=167), 50 mg twice daily (n=168), 140 mg once daily (n=167), or 70 mg twice daily (n=168). Data supported the recommended starting dose, 100 mg once daily, in patients with chronic phase Ph+ CML. The primary endpoint of the CA180-034 study was major cytogenetic response (MCyR) in imatinib-resistant patients. In the study, 63% of imatinib-resistant or -intolerant patients taking dasatinib 100 mg once daily achieved MCyR at two years (95% CI, 0.56-0.71).