Bristol-Myers, Otsuka America Announce FDA Approves US Product Labeling Update for Sprycel to Include Three--Year First-Line, Five-Year Second-Line Efficacy, Safety Data in Chronic Myeloid Leukemia in Chronic Phase

Bristol-Myers Squibb Company BMY and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling. The labeling now includes three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and five-year data in CP Ph+ CML patients who are resistant or intolerant to Gleevec^®1 (imatinib mesylate). Sprycel is a kinase inhibitor indicated for the treatment of adults with newly diagnosed CP Ph+ CML. The effectiveness of Sprycel is based on cytogenetic response and major molecular response rates. The trial is ongoing and further data will be required to determine long-term outcome. Sprycel is also indicated for Ph+ CML in all phases (chronic, accelerated, or myeloid or lymphoid blast) with resistance or intolerance to prior therapy including imatinib and Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. “These longer-term data add to the growing body of research around the safety and efficacy of Sprycel in first-line CP Ph+ CML patients and those who are resistant or intolerant to imatinib,” said Neil Shah, MD, PhD, 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.” “Bristol-Myers Squibb remains committed to helping patients with newly diagnosed and imatinib-resistant or intolerant CP Ph+ CML through treatment with Sprycel, a convenient once-daily treatment option,” said Laura Bessen, MD, vice president and head of U.S. Medical, Bristol-Myers Squibb. “The longer-term safety and efficacy data that have been added to the Sprycel^® (dasatinib) U.S. labeling underscore this longstanding commitment. Since the initial FDA approval in 2006, more than 175,000 Sprycel prescriptions have been written in the U.S.” “We are fortunate to be living at a time when, for many patients, CML can often be managed as a chronic disease, thanks to treatments like Sprycel,” said Greg Stephens, executive director, National CML Society. “As patients continue to benefit from these treatments, understanding their safety and effectiveness over time becomes increasingly important and may help inform the decisions of healthcare providers as to which therapy they choose.” Sprycel Demonstrated Higher Response than Imatinib in Newly-diagnosed Patients Information added to the Sprycel label in the first-line CP Ph+ CML setting is based on three-year data from DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CML Patients), an open-label, randomized, Phase 3 international trial. In the study, Sprycel demonstrated superior efficacy as defined by higher molecular (major molecular response^2 or MMR) and confirmed cytogenetic response rates (CCyR^3) by 12 months, compared to imatinib. In DASISION, 77% [95% CI, 71% - 82%] of patients treated with Sprycel (n=259) vs. 66% [95%, CI, 60% - 72%] of patients treated with imatinib (n=260) achieved the primary endpoint of confirmed CCyR (defined as two consecutive assessments of CCyR at least 28 days apart) by 12 months (p=0.007). After 36 months follow-up, median time to confirmed CCyR was 3.1 months in 214 Sprycel responders and 5.8 months in 201 imatinib responders. In the long-term (by 3 years), confirmed CCyR rates continued to increase (83% Sprycel vs. 77% imatinib).^4 Sprycel patients were more likely than imatinib patients to achieve MMR^2, a measure of deeper treatment response, by year one (52% [95% CI, 46% - 58%] vs. 34% [95% CI, 28% - 40%], respectively; p<0.0001). ^ In the long ^ term (by year 3), MMR at any time was higher for Sprycel than imatinib (69% [95% CI, 63% - 75%] vs. 56% [95% CI, 50% - 62%], respectively).^4 The study also showed higher MMR rates at any time with Sprycel, across all Hasford^5 risk groups vs. imatinib (low risk: 81% vs. 64%; medium risk: 64% vs. 56%; and high risk: 61% vs. 42%). ^ In patients treated with Sprycel^® (dasatinib) the vast majority did not transform to accelerated or blast phase CML by three years (3% with Sprycel and 5% with imatinib). The most frequently reported serious adverse reactions in patients with newly diagnosed CP Ph+ CML included pleural effusion (4%), hemorrhage (2%), congestive heart failure (1%), pulmonary hypertension (1%), and pyrexia (1%). ^ The most frequently reported adverse reactions reported in ≥10% of patients with newly diagnosed CP Ph+ CML included myelosuppression, fluid retention events (pleural effusion and superficial localized edema), diarrhea, headache, musculoskeletal pain, rash, and nausea. ^ The safety and efficacy evaluation in this trial is ongoing.