Most patients (n=109; 96%) received at
least two cycles of treatment and were eligible
for evaluation. After a median follow-up of
20 months (range = 2-43 months), the overall
response rate (ORR; primary endpoint) for
all patients receiving either HMA was 62
percent (n=68), including the 37 percent of
patients (n=40) who achieved a complete
response (CR).
Overall, the median time to best response
was two months (range = 1-20 months),
and the median number of cycles patients
received was nine (range = 1-41 cycles). The
median duration of response was 18 months
in both the decitabine and azacitidine
cohorts (range = 2->40 months and 2->30
months, respectively).
The median event-free survival (EFS) was
18 months (95% CI 14-22) – 20 months in
the decitabine group and 13 months in the
azacitidine group (p=0.1). The median overall
survival (OS) had not been reached.
Females and Males of Reproductive Potential
Pregnancy Testing
VYXEOS can cause fetal harm when administered to a pregnant woman
[see Use in Specific Populations]. Verify the pregnancy status of females
of reproductive potential prior to initiating VYXEOS.
Contraception
Females
Advise females of reproductive potential to use effective contraception
during treatment with VYXEOS and for at least 6 months after the last dose.
Males
Advise males with female partners of reproductive potential to use
effective contraception during treatment with VYXEOS and for at least
6 months after the last dose.
Infertility
Based on findings of daunorubicin and cytarabine in animals, male
fertility may be compromised by treatment with VYXEOS.
In the entire population, the one-year EFS
rate was 65 percent (74% in the decitabine
group and 55% in the azacitidine group) and
the one-year median OS rate was 85 percent
(87% and 83%, respectively).
Of the 57 evaluable patients who were red
blood cell or platelet transfusion–dependent at
baseline (38 treated with decitabine and 19