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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. © 2020 Epizyme, Inc. All Rights Reserved. TZ-FL-BR-20-0109