Important advancement in treatment for patients living with Follicular Lymphoma (FL)

• Dr. M. Yair Levy, Texas Oncology – Baylor Charles A. Sammons Cancer Center

BACKGROUND:
Cancer is a disease that almost everyone will confront at some point in their lives, either personally or through a loved one. As we continue to be impacted by the COVID-19 pandemic, it’s more important than ever to ensure patients receive proper care when managing a chronic cancer, like follicular lymphoma (FL).1

FL is a slow-growing and incurable blood cancer that starts in the lymphatic system, which is a system of lymph nodes found throughout the body, including the neck, underarms, chest, abdomen and groin/pelvis.1 While FL can occur at any age, it is most frequently diagnosed among people aged 55-64, with a median age of 63.2 Of the estimated 74,000 individuals diagnosed with non-Hodgkin lymphoma in the United States each year,3 FL accounts for approximately 20% of all cases, or about 14,800 individuals.1

It’s important for patients and doctors to remember that cancer care should not be put by the wayside due to COVID-19. By having routine and open conversations with healthcare providers via telemedicine and select in-person visits, patients can help to support their own improved health outcomes. There is also new hope as treatment advances give patients with FL, and the doctors who treat them, new, convenient options to help fight this debilitating cancer.

With the FDA’s recent accelerated approval of TAZVERIK® (tazemetostat) for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies, FL patients have a new oral treatment option to discuss with their physicians. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For more information on TAZVERIK, including full Prescribing Information, please visit: www.tazverik.com.4

Dr. M. Yair Levy, Texas Oncology – Baylor Charles A. Sammons Cancer Center, will be available for interviews. He will share details about this recent approval, risk factors, symptoms and treatment options for FL.
Interview is courtesy: Epizyme, Inc.

For more information on FL, please visit: www.lymphomaresearchfoundation.org or www.lls.org
For more information on TAZVERIK, including full Prescribing Information, please visit: www.tazverik.com

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 [AUC0-45h]) 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 full Prescribing Information for TAZVERIK, available at www.tazverik.com

MORE ABOUT DOCTOR*
Dr. Levy received his medical doctorate at the University of Wisconsin at Madison School of Medicine. He served his residency at the University of Pittsburgh Medical Center and his hematology fellowship at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD. He also served on the faculty at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Dr. Levy specializes in hematology, including lymphoma, myeloma and leukemia.

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References:
1. Lymphoma- Non-Hodgkin: Introduction. Cancer.Net. Accessed September 15, 2020. Available at: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/introduction
2. National Cancer Institute (NCI). Surveillance, Epidemiology, and End Results (SEER) Program. Cancer stat facts: NHL – follicular lymphoma. Accessed September 15, 2020. Available at: https://seer.cancer.gov/statfacts/html/follicular.html.
3. About Non-Hodgkin Lymphoma. American Cancer Society. Accessed September 15, 2020. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about.html.
4. TAZVERIK® (tazemetostat) Prescribing Information. Cambridge, Massachusetts, USA: Epizyme, Inc; June 2020.

*Spokespeople are subject to change based on availability. Individual experience with diagnosis and treatment of follicular lymphoma will vary by patient.

Produced for: Epizyme, Inc.
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