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
Page: 1 2 3 4 5 6 7 8 9 Related biology technology :1
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