FDA Approves US Product Labeling Update for Sprycel (Dasatinib)

Bristol-Myers Squibb Company (BMS) and Otsuka America Pharmaceutical have announced that FDA has approved an update to the Sprycel (dasatinib) product labeling. The labeling now includes 5-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and 7-year data in CP Ph+ CML patients who are resistant or intolerant to prior therapy, including Gleevec (imatinib mesylate).

“The 5- and 7-year data now included in the Sprycel US label offer valuable insight into its long-term efficacy and safety profile in both first- and second-line patients,” said Neil Shah, Associate Professor, Division of Hematology/Oncology, University of California, San Francisco. “CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Given the chronic nature of CML, these long-term data are particularly important for patient care.”

“Treating CML across the spectrum of the disease has been an important focus for Bristol-Myers Squibb and Otsuka, and we remain committed to helping newly diagnosed and imatinib-resistant or intolerant CP Ph+ CML patients through treatment with Sprycel, a convenient once-daily treatment option,” said Laura Bessen, Vice President, head of US Medical, BMS. “We are proud to have generated this important 5- and 7-year data in the first- and second-line treatment of CP Ph+ CML, as the findings further support the overall efficacy and safety profile of Sprycel over the long term.”