What You Ought to Know About Relapsed or Refractory Follicular Lymphoma

Every particular person’s expertise with follicular lymphoma (FL) is exclusive. Whether or not you’re residing with FL or caring for somebody who’s, the bodily, emotional and psychosocial results can fluctuate from individual to individual. Regardless of the place you might be in your expertise, it’s necessary to know that assist is offered – and remedy choices are persevering with to increase.

Relapsed or Refractory FL

FL is a slow-growing type of non-Hodgkin’s lymphoma (NHL). Many sufferers with FL don’t have any apparent signs of the illness at first. By the point indicators and signs seem, the illness could already be at a extra superior stage (stage 3 or 4).¹ The encouraging information is that preliminary remedies usually work nicely, and sufferers can expertise lengthy durations of remission. Nevertheless, for a lot of sufferers, the lymphoma can return after remedy or it might cease responding to remedy.² When this occurs, the illness is named “relapsed” or “refractory” (R/R) FL.³

In some circumstances, FL can flip right into a extra aggressive illness. Danger of FL transformation to DLBCL varies; in a single research, the speed of transformation was 16% at 10 years.^4,5,6 About one in 5 individuals identified with FL will expertise illness development inside the first two years of preliminary remedy.⁷

Remedies for R/R FL

For sufferers with FL whose illness has progressed or returned, your physician could suggest one other sort of remedy. These could embody:

• Chemoimmunotherapy – A mix remedy that makes use of chemotherapy, a remedy that kills most cancers cells, and immunotherapy, which stimulates or boosts the immune system’s means to acknowledge and destroy most cancers cells.^8,9
• Radiation remedy – A kind of remedy that makes use of beams of high-energy to abolish most cancers cells and shrink tumors. Additionally it is generally known as radiotherapy.¹⁰
• Monoclonal antibodies – Lab-produced molecules that function different antibodies that mimic the physique’s immune system to acknowledge, assault, and destroy most cancers cells.⁹
• CAR T-cell remedy – A kind of immunotherapy the place a affected person’s personal T cells are genetically modified to acknowledge and assault most cancers cells.⁹
• Bispecific antibodies – An antibody remedy that makes use of the ability of your personal immune system to assist battle most cancers by recognizing two completely different targets on most cancers cells.⁹

“Individuals residing with follicular lymphoma know that they are going to dwell with this most cancers for the remainder of their lives, and lots of will finally expertise relapse,” says Dr. Mitchell R. Smith, M.D., Ph.D., Chief Medical Officer, Follicular Lymphoma Basis. “The excellent news is that as we speak, sufferers have quite a lot of remedy choices out there to them and analysis continues to point out promise with new advances. Which means that sufferers could make selections with their care group primarily based on their remedy historical past and what’s most necessary to them.”

Therapy Choices are Increasing

Lately, a category of therapies referred to as bispecific antibodies have been accredited for the remedy of R/R FL that has come again or that didn’t reply to earlier remedy after receiving two or extra remedies and could also be an possibility for sure sufferers. Bispecific antibodies work along with your immune system to assist battle most cancers.¹¹ Bispecific antibody remedies are “off-the-shelf,” that means that they are often made out there to deal with sufferers quickly after relapse or illness development.¹² That is significantly important for sufferers who want pressing remedy.

“The introduction of bispecific antibodies for follicular lymphoma has been an necessary development for sufferers. A few of these remedies may be administered till illness development, which can assist guarantee the medication retains working in individuals’s our bodies, serving to them keep remission,” says Dr. Habte A. Yimer, M.D., Chair, Hematology/Oncology, Christus Trinity Mom Frances Hospital, Texas Oncology. “For these with relapsed or refractory follicular lymphoma, bispecific antibodies have additionally been confirmed to work in sure sufferers who have been refractory to their final remedy, and sufferers whose illness has progressed inside two years of first-line chemoimmunotherapy.”

One out there bispecific antibody is EPKINLY® (epcoritamab-bysp). EPKINLY is a prescription drugs used to deal with adults with sure varieties of DLBCL, high-grade B-cell lymphoma, or FL that has come again or that didn’t reply to earlier remedy after receiving two or extra remedies.¹³ In truth, it’s the first and solely bispecific remedy accredited for each DLBCL and FL. EPKINLY is the one bispecific antibody administered subcutaneously (an injection given just below the pores and skin), providing sufferers an progressive remedy possibility that will allow remedy at an oncologist’s workplace.

EPKINLY works by focusing on two cells in a affected person’s physique: T cells and B cells. T cells are immune cells that battle an infection and illness. B cells are additionally immune cells, however some can grow to be cancerous and develop uncontrollably within the physique. EPKINLY binds these cells collectively in order that the T cells can assault and destroy B cells.¹²

In scientific trials, 82% of FL sufferers who have been handled with EPKINLY responded to remedy, with 60% of responders reaching an entire response, which suggests indicators of most cancers disappeared fully.¹³ Some sufferers achieved ends in as few as 4 weeks (median (the quantity that’s precisely in the course of the vary seen within the research) of 1.4 months; time different from 1 to three months).¹³

The most typical (≥20%) hostile reactions have been injection website reactions, cytokine launch syndrome (CRS), COVID-19, fatigue, higher respiratory tract an infection, musculoskeletal ache, rash, diarrhea, fever, cough, and headache.¹³

Surrounding Your self with Assist

Whereas each affected person’s expertise with FL could also be completely different, there are assets to assist.

“It’s necessary that sufferers, care companions, and their healthcare suppliers have the assist and assets they should navigate their distinctive remedy experiences,” mentioned Ron Graybill, Vice President, US Market Entry, Genmab. “MyNavCare Affected person Assist™ is one program that’s out there to sufferers who’ve been prescribed EPKINLY that gives complete assets regardless of the place you might be in your remedy expertise, from illness data to monetary help and dwell assist.”

“A vital consider navigating a most cancers analysis is discovering a care group you’re feeling comfy with, so shared decision-making can happen and belief may be constructed,” shares Allam Fakhoury, PharmD, RPh, Therapeutic Space Lead Hematology Oncology, AbbVie. “Having open and sincere conversations is vital in a affected person’s remedy journey.”

What’s EPKINLY?¹³
EPKINLY is a prescription drugs used to deal with adults with sure varieties of diffuse giant B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come again or that didn’t reply to earlier remedy after receiving 2 or extra remedies. EPKINLY is accredited primarily based on affected person response knowledge. Research are ongoing to substantiate the scientific advantage of EPKINLY. It isn’t recognized if EPKINLY is secure and efficient in kids.

IMPORTANT SAFETY INFORMATION

Necessary Warnings—EPKINLY may cause severe uncomfortable side effects, together with:

• Cytokine launch syndrome (CRS), which is frequent throughout remedy with EPKINLY and may be severe or life-threatening. To assist cut back your danger of CRS, you’ll obtain EPKINLY on a step-up dosing schedule (whenever you obtain 2 or 3 smaller step-up doses of EPKINLY earlier than your first full dose throughout your first cycle of remedy), and you may additionally obtain different medicines earlier than and for 3 days after receiving EPKINLY. In case your dose of EPKINLY is delayed for any cause, you could have to repeat the step-up dosing schedule.
• Neurologic issues that may be severe, and may be life-threatening and result in dying. Neurologic issues could occur days or even weeks after you obtain EPKINLY.

Individuals with DLBCL or high-grade B-cell lymphoma needs to be hospitalized for twenty-four hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 because of the danger of CRS and neurologic issues.

Inform your healthcare supplier or get medical assist instantly in the event you develop a fever of 100.4°F (38°C) or greater; dizziness or lightheadedness; bother respiration; chills; quick heartbeat; feeling anxious; headache; confusion; shaking (tremors); issues with stability and motion, resembling bother strolling; bother talking or writing; confusion and disorientation; drowsiness, tiredness or lack of power; muscle weak spot; seizures; or reminiscence loss. These could also be signs of CRS or neurologic issues. When you’ve got any signs that impair consciousness, don’t drive or use heavy equipment or do different harmful actions till your signs go away.

EPKINLY may cause different severe uncomfortable side effects, together with:

• Infections that will result in dying. Your healthcare supplier will examine you for indicators and signs of an infection earlier than and through remedy and deal with you as wanted in the event you develop an an infection. You must obtain medicines out of your healthcare supplier earlier than you begin remedy to assist stop an infection. Inform your healthcare supplier instantly in the event you develop any signs of an infection throughout remedy, together with fever of 100.4°F (38°C) or greater, cough, chest ache, tiredness, shortness of breath, painful rash, sore throat, ache throughout urination, or feeling weak or typically unwell.
• Low blood cell counts, which may be severe or extreme. Your healthcare supplier will examine your blood cell counts throughout remedy. EPKINLY could trigger low blood cell counts, together with low white blood cells (neutropenia), which may improve your danger for an infection; low crimson blood cells (anemia), which may trigger tiredness and shortness of breath; and low platelets (thrombocytopenia), which may trigger bruising or bleeding issues.

Your healthcare supplier will monitor you for signs of CRS, neurologic issues, infections, and low blood cell counts throughout remedy with EPKINLY. Your healthcare supplier could briefly cease or fully cease remedy with EPKINLY in the event you develop sure uncomfortable side effects.

Earlier than you obtain EPKINLY, inform your healthcare supplier about all of your medical situations, together with in the event you have an an infection, are pregnant or plan to grow to be pregnant, or are breastfeeding or plan to breastfeed. In the event you obtain EPKINLY whereas pregnant, it might hurt your unborn child. If you’re a feminine who can grow to be pregnant, your healthcare supplier ought to do a being pregnant check earlier than you begin remedy with EPKINLY and it is best to use efficient contraception (contraception) throughout remedy and for 4 months after your final dose of EPKINLY. Inform your healthcare supplier in the event you grow to be pregnant or suppose that you could be be pregnant throughout remedy with EPKINLY. Don’t breastfeed throughout remedy with EPKINLY and for 4 months after your final dose of EPKINLY.

In DLBCL or high-grade B-cell lymphoma, the commonest uncomfortable side effects of EPKINLY embody CRS, tiredness, muscle and bone ache, injection website reactions, fever, stomach-area (stomach) ache, nausea, and diarrhea. The most typical extreme irregular laboratory check outcomes embody decreased white blood cells, decreased crimson blood cells, and decreased platelets.

In follicular lymphoma the commonest uncomfortable side effects of EPKINLY embody injection website reactions, CRS, COVID-19, tiredness, higher respiratory tract infections, muscle and bone ache, rash, diarrhea, fever, cough, and headache. The most typical extreme irregular laboratory check outcomes embody decreased white blood cells and decreased crimson blood cells.

These usually are not all the doable uncomfortable side effects of EPKINLY. Name your physician for medical recommendation about uncomfortable side effects.

You’re inspired to report uncomfortable side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medicine Information, together with Necessary Warnings.

1. Follicular Lymphoma. Lymphoma Motion. https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/follicular-lymphoma#remedy. Accessed February 2025.
2. Follicular Lymphoma: Therapy Choices. Lymphoma Analysis Basis. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/fltreatment/. Accessed March 2025.
3. Follicular Lymphoma: Relapsed/Refractory. Lymphoma Analysis Basis. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/. Accessed February 2025.
4. Zheng W, Liu M, Guan L, Wang S. Outcomes of the transformation of follicular lymphoma to diffuse giant B-cell lymphoma within the rituximab period: A population-based research. Most cancers Med. 2024;13(8):e7120. doi:10.1002/cam4.7120
5. Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Inhabitants -based evaluation of incidence and final result non-Hodgkin’s lymphoma. J Clin Oncol. 2008 Nov 10; 26(32):5165-9. doi: 10.1200/JCO.2008.16. 2008 Oct 6. PMID: 18838711.
6. Batlevi CL, Sha F, Alperovich A, et al. Follicular lymphoma within the fashionable period: survival, remedy outcomes, and identification of high-risk subgroups. Blood Most cancers J. 2020;10(7):74. doi:10.1038/s41408-020-00340-z
7. Casulo, et al. Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Sufferers at Excessive Danger for Loss of life: An Evaluation From the Nationwide LymphoCare Research. J Clin Oncol. 2015 Jun 29;33(23):2516–2522. doi: 10.1200/JCO.2014.59.7534
8. Therapy Choices: Chemotherapy. https://lymphoma.org/understanding-lymphoma/treatment-planning-and-options/remedies/chemotherapy/. Accessed March 2025.
9. Therapy Choices: Immunotherapy. https://lymphoma.org/understanding-lymphoma/treatment-planning-and-options/remedies/immunotherapy/. Accessed March 2025.
10. Therapy Choices: Radiation Remedy. https://lymphoma.org/understanding-lymphoma/treatment-planning-and-options/remedies/radiation/. Accessed March 2025.
11. Evaluate of present standing and prospects for bispecific antibodies. https://www.biochempeg.com/article/252.html. Accessed June 2025.
12. EPKINLY Affected person Brochure. https://www.epkinly.com/content material/dam/epcoritamab/docs/dlbcl-patient-brochure.pdf. Accessed March 2025.
13. EPKINLY [package insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2023.

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