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Expanding the Bispecific Antibody Market from CAR-Ts to Drive Follicular Lymphoma's Future | DelveInsight

For those in the early stages of the disease (Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are RITUXAN (rituximab) and GAZYVA (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like ZEVALIN (yttrium-90 ibritumomab tiuxetan), TAZVERIK (tazemetostat), REVLIMID (lenalidomide), and others are approved for the treatment of follicular lymphoma.
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For those in the early stages of the disease ( Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are (rituximab) and (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like (yttrium-90 ibritumomab tiuxetan), (tazemetostat), (lenalidomide), and others are approved for the treatment of follicular lymphoma.

CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. , a CD19-directed genetically modified autologous T-cell therapy, became the . Before the approval of YESCARTA, that Later in . In May 2024 BREYANZI was approved for the treatment of relapsed/refractory follicular lymphoma who have received two or more prior lines of systemic therapy and provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months.

In , Novartis announced that the (tisagenlecleucel) for adult patients with . This approval represents the third indication for KYMRIAH, making it the first CAR-T cell therapy sanctioned in Europe for such patients, including those with relapsed/refractory follicular lymphoma Grades 1, 2, and 3A. Additionally, in , the granted approval for for the same patient group.

Currently, autologous CAR-T therapies are the only ones approved, but the emerging pipeline predominantly comprises autologous CAR-Ts alongside a growing number of allogeneic CAR-T therapies. Allogeneic CAR-T, a newer term, refers to donor-derived therapies offering several advantages over autologous treatments. These off-the-shelf therapies are readily available, eliminating the need to modify patient cells either at a central manufacturing site or at the point of care. Even though the reimbursement of CAR-T therapies represents a challenge for healthcare providers, insurers, and government agencies, they have successfully reached the majority of the markets by considering the patient pool demand. While determining the cost and reimbursement, various factors, such as pharmacoeconomic analysis and outcome-based responses, as well as the added value to society, have been evaluated. The CAR T-cell-related toxicity, such as the cytokine-release syndrome and neurotoxicity, remain important potential complications of this therapy. Second generation CAR T-cell therapies are emerging with more safety and efficacy to overcome these limitations. If these limitations have been overcome, these are going to be the potential drivers of the market. 

After CAR-T approval companies focused on developing alternative therapies to overcome CAR-Ts limitations. became the first bispecific antibody to get Later in December 2022 , the US FDA approved it for the same indication. This was the game changing step toward a brighter future for follicular lymphoma patients. . In , captured .

In the United States , AbbVie and Genmab's epcoritamab, marketed as , first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its . With the recent FDA authorization for relapsed/refractory follicular lymphoma, along with expected approvals and launches in international markets, EPKINLY is poised to see revenue growth in the coming quarters. .

for the expanded use of AbbVie and Genmab's bispecific antibody, (epcoritamab), for treating adults with . The study showed an overall response rate of 83% and a complete response rate of 63%, with the median response duration being 21.4 months. 

Just after TEPKINLY approval in Europe , (odronextamab) a CD20 x CD3 bispecific antibody for the treatment of adult patients with , after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the . In and . The agency issued two complete response letters concerning the biologics license application (BLA) for odronextamab in relapsed/refractory follicular lymphoma and DLBCL after two or more lines of systemic therapy. The assessing the drug. Importantly, there were no concerns raised about odronextamab's efficacy, safety, trial design, labeling, or manufacturing.

Both EPKINLY, LUNSUMIO, and ORDSPONO are off-the-shelf therapies, offering greater accessibility compared to CD19 CAR-T treatments. These drugs will compete not only with each other but also with CAR-T therapies to secure a substantial portion of the follicular lymphoma market.

Learn more about the FDA-approved follicular lymphoma drugs @

A new class has also emerged for the treatment of follicular lymphoma, i.e., (BTK) inhibitors. In November 2023 , BeiGene received approval from the European Commission for (zanubrutinib) to treat relapsed/refractory follicular lymphoma. Later in March 2024 , the US FDA approved BRUKINSA  for the same indication. BRUKINSA is the first and only BTK inhibitor approved for this condition.

To know more about follicular lymphoma treatment options, visit @

The follicular lymphoma pipeline is robust with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include , , , , , and others.

Discover which therapies are expected to grab major follicular lymphoma market share @

 is an anti-cancer medication available in various forms, including hard gelatin capsules, tablets, film-coated tablets, and oral suspension. It is being developed by AbbVie and is currently undergoing Phase III trials for follicular lymphoma. This study aims to determine if adding ibrutinib to the treatment will extend progression-free survival (PFS) compared to using rituximab alone in patients with newly diagnosed follicular lymphoma.

 is developing for treating follicular lymphoma. The company is currently testing this investigational drug in a Phase II clinical trial involving patients with relapsed/refractory follicular lymphoma who have received at least three prior therapies. The US FDA has granted Abexinostat for this use. In June 2021 , Xynomic completed a short-form merger with Xu-Nuo Pharma in a "Going Private" transaction. Post-merger, Xu-Nuo Pharma will continue Xynomic's business as its main focus.

Discover more about drugs for follicular lymphoma in development @

The anticipated launch of these emerging therapies for follicular lymphoma are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the follicular lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for follicular lymphoma is expected to grow from in 2020 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rise in the increasing incidence of follicular lymphoma.

DelveInsight's latest published market report titled as  will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the follicular lymphoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The follicular lymphoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include:

Download this follicular lymphoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the follicular lymphoma market. Also, stay abreast of the mitigating factors to improve your market position in the follicular lymphoma therapeutic space.

 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key follicular lymphoma companies, including among others.

 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including , among others.

 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including among others.

 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including , among others.

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve

Shruti Thakur  
info@delveinsight.com
+14699457679

 

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