ASH_6.9_full issue | Page 22
On Location
(15.3% vs. 2%, respectively; p<0.05). Dr. Tam
noted that with prolonged therapy, ibrutinib may
be associated with higher cardiovascular toxicity
than zanubrutinib.
With a median follow-up of 19.4 months,
the combined CR and VGPR rate in the entire
study population, as assessed by an independent
review committee (IRC), was higher with
zanubrutinib than ibrutinib (28.4% vs. 19.2%,
respectively; p=0.09). The investigator-assessed
CR and VGPR rate for zanubrutinib was the
same as the IRC-assessed rate (28.4%) but was
slightly lower for ibrutinib (17.4%), so for this
comparison a two-sided descriptive p value did
achieve statistical significance (p=0.04). The
major response rate, which also includes partial
responses in addition to CR and VGPR, was
roughly equal between groups (zanubrutinib:
77.5% vs. ibrutinib: 77.8%).
Dr. Tam added that the rates of progressionfree
survival (PFS) at 12 months were excellent
for both zanubrutinib and ibrutinib (89.7% and
87.2%, respectively). So far, he said, there have
been no differences between the treatment
groups in terms of overall survival (OS). The
12-month OS rates were 97% for zanubrutinib
and 93.9% for ibrutinib. The quality of life (QoL)
Important Safety Information
Warnings and Precautions
• Secondary Malignancies
The risk of developing secondary malignancies is increased following treatment with TAZVERIK.
Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic
syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric
patient developed T-cell lymphoblastic lymphoma (T-LBL). Monitor patients long-term for the
development of secondary malignancies.
• Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, TAZVERIK can cause
fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in
pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant
rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal
developmental abnormalities in both species beginning at maternal exposures approximately
1.5 times the adult human exposure (area under the plasma concentration time curve [AUC 0-45h ])
at the 800 mg twice daily dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose.
Advise males with female partners of reproductive potential to use effective contraception during
treatment with TAZVERIK and for 3 months after the final dose.
Adverse Reactions
In 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK
800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK.
Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal
pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue
(36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and
abdominal pain (20%).
Drug Interactions
Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration
of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.
Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may
decrease the efficacy of TAZVERIK.
Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives,
can result in decreased concentrations and reduced efficacy of CYP3A substrates.
Lactation
Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child,
advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.
Please see brief summary of the Prescribing Information on the adjacent pages.
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