Median time—
the first follow-up, per protocol
Powerful efficacy,
chemotherapy free
0
1.9
months
1
2
3
Demonstrated single-agent efficacy in an open-label, pivotal, phase 2 trial2†
Range=1.6 to 8.3 months
ZYDELIG in FL (n=72)
ORR
Response (%)
60
POWER
of response
40
20
0
54
%
(95% CI, 42%-66%)
8% CR, 46% PR
Median DoR
Not reached
DURATION
of response
0
3
6
9
12
15
Range=0.0+ to 14.8+ months
CI=confidence interval; CR=complete response; DoR=duration of response; PR=partial response.
†Results of a single-arm, open-label trial of ZYDELIG (150 mg, twice daily) in patients with FL who failed to respond or relapsed after ≥2 prior therapies (which must have
included both rituximab and an alkylating agent). Primary end point was ORR, as assessed by an independent review committee. ORR was defined as the proportion of
subjects who achieved CR or PR. Secondary end point was DoR. DoR was measured from the onset of first documented response (CR or PR) to disease progression or death.2
• Most common adverse reactions (incidence ≥20%; all grades) were diarrhea,
fatigue, nausea, cough, pyrexia, abdominal pain, pneumonia, and rash; 53%
of patients discontinued or interrupted therapy due to adverse reactions
Drug Interactions
• CYP3A inducers: Avoid coadministration with
strong CYP3A inducers
• CYP3A inhibitors: When coadministered with
strong CYP3A inhibitors, monitor closely for
ZYDELIG toxicity
• CYP3A substrates: Avoid coadministration with
CYP3A substrates
Dosage and Administration
• Adult starting dose: One 150 mg tablet twice
daily, swallowed whole with or without food.
Continue treatment until disease progression or
unacceptable toxicity. The safe dosing regimen
for patients who require treatment longer than
several months is unknown
• Dose modification: Consult the ZYDELIG full
Prescribing Information for dose modification and
monitoring recommendations for the following
specific toxicities: pneumonitis, ALT/AST
elevations, bilirubin elevations, diarrhea,
neutropenia, and thrombocytopenia. For other
severe or life-threatening toxicities, withhold
ZYDELIG until toxicity is resolved and reduce the
dose to 100 mg, twice daily, upon resuming
treatment. If severe or life-threatening toxicities
recur upon rechallenge, ZYDELIG should be
permanently discontinued
Please see the following pages for Brief Summary
of full Prescribing Information, including
BOXED WARNING.
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