FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic... (mg twice daily andGleevec 800 mg (400 mg...)

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

Date:11/8/2007

mg twice daily and Gleevec 800 mg (400 mg twice daily) in 150 patients with chronic-phase CML resistant to prior Gleevec doses of 400 or 600 mg. For patients receiving SPRYCEL, at 12 weeks 36 percent achieved a major cytogenetic response, the study's primary endpoint (29 percent with Gleevec), and 22 percent achieved a complete cytogenetic response (8 percent with Gleevec). With longer treatment and follow-up, 52 percent achieved a major cytogenetic response (33 percent with Gleevec), and 40 percent of patients achieved a complete cytogenetic response (16 percent with Gleevec). The rate of major cytogenetic response with SPRYCEL was lower among patients aged 65 years and over.

At the time of analysis, 39 of 49 patients receiving Gleevec had crossed over to SPRYCEL; 15 of 101 patients receiving SPRYCEL had crossed over to Gleevec. Crossover to alternate therapy was permitted in the event of disease progression or intolerable toxicity. Median duration of treatment prior to crossover was 14 months for SPRYCEL and three months for Gleevec.

Incidence of selected adverse reactions (all grades) in the Phase 2 randomized study in patients receiving SPRYCEL 70 mg twice daily or Gleevec 800 mg daily (400 mg twice daily) included diarrhea (37%, 29%); fluid retention events (36%, 43%) such as pleural effusion (23%, 0%), superficial edema (17%, 41%), generalized edema (2%, 4%), congestive heart failure/cardiac dysfunction (2%, 0%), pericardial effusion (1%, 0%), pulmonary edema (3%, 0%), pulmonary hypertension (1%, 0%); nausea (24%, 33%); hemorrhage (18%, 8%) including gastrointestinal bleeding (3%, 0%), and vomiting (10%, 24%).

In this same study, the frequency of Grade 3/4 neutropenia, thrombocytopenia, and anemia was 63%, 56%, and 19%, respectively, in the SPRYCEL group and 39%, 14%, and 8%, respectively, in the Gleevec group. The frequency of Grade 3/4 hypocalcemia was 4% in the SPRYCEL group and 0% in the Gleevec group.

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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic...(mg twice daily andGleevec 800 mg (400 mg...)