Follicular Lymphoma Pipeline Insight 2025: Next-Gen Anti-CD20 Therapies, Bispecific Antibodies, and Cell Therapies Redefine the Standard of Care | DelveInsight

DelveInsight's "Follicular Lymphoma - Pipeline Insight, 2025" provides a detailed exploration of the evolving therapeutic landscape for this indolent but incurable subtype of non-Hodgkin lymphoma (NHL). Often marked by frequent relapses and progressive resistance to standard immunochemotherapy, Follicular Lymphoma (FL) remains a major clinical challenge, especially in relapsed/refractory (R/R) settings.

The 2025 pipeline highlights a surge of next-generation anti-CD20 monoclonal antibodies, bispecific T-cell engagers (BiTEs), and CAR-T cell therapies aiming to improve durability of response and address unmet needs in later lines. Agents such as Genmab/AbbVie's epcoritamab (a subcutaneous CD3xCD20 bispecific) and Roche's glofitamab (IV CD20xCD3 BiTE) are showing deep and durable remissions in R/R FL cohorts, including those with double-refractory disease.

Autologous CAR-T therapies like Gilead/Kite's Yescarta (axi-cel) and Novartis' Kymriah (tisagenlecleucel) have gained FDA approval for third-line FL, with promising long-term follow-up data. Meanwhile, allogeneic CAR-T platforms and off-the-shelf natural killer (NK) cell therapies are advancing through early-phase trials, offering potentially faster, more scalable alternatives.

Oral EZH2 inhibitors such as Epizyme's Tazverik (tazemetostat) are also gaining ground in EZH2-mutated and wild-type populations alike, offering a non-cytotoxic option for select patients. In parallel, immunomodulatory agents, BTK inhibitors, and PI3K inhibitors are being repositioned with improved safety profiles and better combinatory potential.

From a regulatory and market perspective, orphan drug designations, breakthrough therapy status, and real-world data integration are accelerating timelines. Clinical trials are increasingly incorporating MRD (minimal residual disease) assessments, patient-reported outcomes, and time-to-next-treatment metrics to better capture long-term benefit.

With a strong pipeline focused on targeted, immune-engaging, and cell-based strategies, Follicular Lymphoma treatment is poised to shift toward individualized, chemotherapy-free regimens that may offer true disease modification for a wider population of patients.

Interested in learning more about the current treatment landscape and the key drivers shaping the follicular lymphoma pipeline? Click here: https://www.delveinsight.com/report-store/follicular-lymphoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Follicular Lymphoma Pipeline Report
• DelveInsight's follicular lymphoma pipeline analysis depicts a strong space with 45+ active players working to develop 50+ pipeline drugs for follicular lymphoma treatment.
• The leading follicular lymphoma companies include Mab Works, AstraZeneca, ADC Therapeutics, Xynomic Pharmaceuticals, AbbVie, Nurix, InnoCare Pharma, LTZ Therapeutics, Hutchmed, Regeneron Pharmaceuticals, Pfizer, InnoCare Pharma, TriSalus Life Sciences, BeiGene, and others are evaluating their lead assets to improve the follicular lymphoma treatment landscape.
• Key follicular lymphoma pipeline therapies in various stages of development include MIL62, AZD0486, Acalabrutinib, Loncastuximab tesirine, Abexinostat, ABBV-319, NX-2127, ICP 248, LTZ-301, HMPL-689, Odronextamab, PF-06821497, ICP-248, Nelitolimod, Zanubrutinib, and others.
• In July 2025, Knight Therapeutics' Brazilian affiliate, United Medical Ltda., submitted a supplemental application to ANVISA for approval of MINJUVI® (tafasitamab) with rituximab and lenalidomide to treat adults with previously treated follicular lymphoma.
• In July 2025, the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of odronextamab, a bispecific antibody targeting CD20 and CD3, for relapsed/refractory follicular lymphoma after two or more lines of systemic therapy
• In June 2025, the FDA approved tafasitamab-cxix (MONJUVI) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).

Request a sample and discover the recent breakthroughs happening in the follicular lymphoma pipeline landscape at https://www.delveinsight.com/report-store/follicular-lymphoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Follicular Lymphoma Overview
Follicular lymphoma (FL) is the most common type of indolent (slow-growing) non-Hodgkin lymphoma (NHL), originating from B lymphocytes within the lymph nodes. It typically affects older adults and is characterized by a relapsing-remitting course. FL often presents with painless lymphadenopathy (swollen lymph nodes), fatigue, or, less commonly, systemic "B symptoms" such as fever, night sweats, and weight loss. While generally not considered curable, FL is often highly treatable, and many patients can live for years with periodic treatment.

Diagnosis is based on lymph node biopsy, immunophenotyping (typically CD20+, CD10+, BCL2+), and imaging studies. Management strategies depend on the stage and symptoms, ranging from a "watch and wait" approach in asymptomatic early-stage cases to immunochemotherapy (e.g., rituximab with bendamustine or CHOP), targeted therapies (e.g., PI3K inhibitors, BTK inhibitors), or novel immunotherapies like CAR T-cell therapy and bispecific antibodies in relapsed/refractory disease. Regular monitoring is essential due to the risk of transformation into a more aggressive lymphoma, such as diffuse large B-cell lymphoma (DLBCL).

Find out more about Follicular Lymphoma medication at https://www.delveinsight.com/report-store/follicular-lymphoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Follicular Lymphoma Treatment Analysis: Drug Profile
MIL62: Mab Works
MIL62 is a third-generation anti-CD20 antibody uniquely positioned in the market as the first domestically developed third-generation anti-CD20 antibody to enter Phase III registration trials in China. Developed using Mab Works' ADCC-enhanced antibody platform, MIL62 has demonstrated stronger antibody-dependent cellular cytotoxicity (ADCC) and superior anti-tumor effects in both in vitro and in vivo studies compared to first-generation antibodies like rituximab and other third-generation antibodies such as obinutuzumab. The company is prioritizing regulatory approval from China's NMPA for treating relapsed and/or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) patients, while also developing MIL62 for frontline treatment in these larger patient populations by showcasing clinical superiority over rituximab. MIL62 is currently in Phase III development for follicular lymphoma.

AZD0486: AstraZeneca
AZD0486, also known as TNB-486, is a bispecific antibody developed by AstraZeneca that targets CD19 and CD3 to boost T-cell-mediated killing of malignant B cells, especially in relapsed or refractory follicular lymphoma patients. By engaging T-cells directly to attack B-cell cancers, AZD0486 overcomes some limitations of conventional therapies. It incorporates a low-affinity anti-CD3 component designed to reduce the severity of cytokine release syndrome (CRS), a common adverse effect of T-cell engaging therapies, enabling a more controlled immune response and potentially improving safety. AZD0486 is currently in Phase III clinical trials for follicular lymphoma.

Abexinostat: Xynomic Pharmaceuticals
Abexinostat (Abx), developed by Xynomic Pharmaceuticals, is a novel, potent oral pan-histone deacetylase inhibitor (HDACi) designed for twice-daily dosing to maintain effective anti-tumor levels. By inhibiting multiple HDAC enzymes involved in histone deacetylation, Abexinostat promotes chromatin remodeling, leading to increased acetylation of histones, which induces apoptosis, cell cycle arrest, and blocks angiogenesis in cancer cells. Additionally, it acts as a Rad51 recombinase inhibitor, disrupting DNA repair processes to enhance its anticancer effects. Abexinostat is currently being evaluated in Phase II clinical trials for the treatment of follicular lymphoma.

Learn more about the novel and emerging follicular lymphoma pipeline therapies at https://www.delveinsight.com/report-store/follicular-lymphoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Follicular Lymphoma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Follicular Lymphoma Pipeline Report
• Coverage: Global
• Key Follicular Lymphoma Companies: Mab Works, AstraZeneca, ADC Therapeutics, Xynomic Pharmaceuticals, AbbVie, Nurix, InnoCare Pharma, LTZ Therapeutics, Hutchmed, Regeneron Pharmaceuticals, Pfizer, InnoCare Pharma, TriSalus Life Sciences, BeiGene, and others.
• Key Follicular Lymphoma Pipeline Therapies: MIL62, AZD0486, Acalabrutinib, Loncastuximab tesirine, Abexinostat, ABBV-319, NX-2127, ICP 248, LTZ-301, HMPL-689, Odronextamab, PF-06821497, ICP-248, Nelitolimod, Zanubrutinib, and others.

To dive deep into rich insights for drugs used for follicular lymphoma treatment, visit: https://www.delveinsight.com/report-store/follicular-lymphoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Follicular Lymphoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Follicular Lymphoma Pipeline Therapeutics
6. Follicular Lymphoma Pipeline: Late-Stage Products (Phase III)
7. Follicular Lymphoma Pipeline: Mid-Stage Products (Phase II)
8. Follicular Lymphoma Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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This release was published on openPR.