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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Date:11/8/2007

with Gleevec-resistant chronic phase CML. A total of 670 patients (498 Gleevec resistant) were randomized to 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily. Those patients who received SPRYCEL once daily achieved a comparable (non-inferior) major cytogenetic response to those who received SPRYCEL twice daily. The rate of major cytogenetic response was lower among patients aged 65 years and over. The median duration of treatment was approximately eight months. The study supports the new recommended starting dose, 100 mg once daily, for chronic-phase CML.

Incidence of selected adverse reactions (all grades) in the Phase 3 dose- optimization study in chronic-phase CML patients receiving SPRYCEL 100 mg once daily (n=165) or SPRYCEL 70 mg twice daily (n=167) included diarrhea (23%, 25%); fluid retention events (24%, 32%) such as superficial edema (14%, 16%), pleural effusion (10%, 18%), generalized edema (2%, 1%), congestive heart failure/cardiac dysfunction (0%, 4%), pericardial effusion (1%, 2%), pulmonary edema (0%, 2%), pulmonary hypertension (0%, 1%), and hemorrhage (10%, 14%) including gastrointestinal bleeding (1%, 4%).

In this same study, the frequency of Grade 3/4 neutropenia, thrombocytopenia, and anemia was 34%, 22%, and 10%, respectively, in the SPRYCEL 100 mg once-daily group and 43%, 38%, and 17%, respectively, in the SPRYCEL 70 mg twice-daily group. The frequency of Grade 3/4 hypophosphatemia and hypocalcemia was 8% and 2%, respectively, in the SPRYCEL 100 mg once-daily group, and 7% and 2%, respectively, in the SPRYCEL 70 mg twice-daily group.

The starting dose for adults with accelerated-phase, myeloid or lymphoid blast-phase CML or adults with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) resistant or intolerant to prior therapy remains at 70 mg twice daily.

SPRYCEL and Escalated Doses of Gleevec (Study -017): The Phase 2 randomized, open-label study evaluated SPRYCEL 70
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SOURCE Bristol-Myers Squibb Company
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