FDA Updates CML Treatment Label

The FDA has approved a product labeling update for Bristol-Myers Squibb and Otsuka’s chronic myeloid leukemia (CML) drug dasatinib (Sprycel)

The label now includes 5-year first-line efficacy and safety data in adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP), as well as 7-year second-line data in Ph+ CML patients in CP who are resistant or intolerant to prior therapy, including imatinib mesylate (Gleevec).

Neil Shah, MD, PhD, associate professor in the Division of Hematology/Oncology at the University of California, San Francisco, stated that these new data “offer valuable insight into [the drug’s] long-term efficacy and safety profile in both first- and second-line patients.”

“CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly,” Dr. Shah stated. “Given the chronic nature of CML, these long-term data are particularly important for patient care.”

Bristol-Myers Squibb recently launched Sprycel Assist, which offers assistance for health care professionals, patients, and caregivers. The program’s services include no co-pay for eligible commercially

insured patients and support throughout the reimbursement process.

Patients considering Sprycel should be aware that the treatment is associated with myelosuppression, bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, and embryo-fetal toxicity.