The FINANCIAL — Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. on August 13 announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling.
The labeling now includes five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in CP Ph+ CML patients who are resistant1 or intolerant2 to prior therapy, including Gleevec (imatinib mesylate).
“The five- and seven-year data now included in the Sprycel U.S. label offer valuable insight into its long-term efficacy and safety profile in both first- and second-line patients,” 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.”
Sprycel is associated with the following warnings and precautions: myelosuppression, bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, and embryo-fetal toxicity, according to Bristol-Myers Squibb Company.
“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, MD, Vice President, head of U.S. Medical, Bristol-Myers Squibb. “We are proud to have generated this important five- and seven-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.”
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