Tazemetostat Hydrobromide

The competition in follicular lymphoma is rapidly intensifying, with three CAR-T therapies and three bispecific antibodies now approved for relapsed or refractory patients. As both classes of treatments expand, the battle for dominance in this market is growing, with each therapy offering unique advantages in accessibility, efficacy, and safety profiles, setting the stage for a dynamic shift in treatment strategies. LAS VEGAS, Sept. 16, 2024 /PRNewswire/ -- Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) that develops from B-lymphocytes and is generally slow-growing or indolent. This subtype represents 20–30% of all NHL cases. While follicular lymphoma typically progresses slowly, there are instances where it can grow more rapidly. Treatment options for follicular lymphoma include, chemotherapy, radiation therapy, immunotherapy, stem cell transplantation, CAR T-cell therapy, and bispecific-antibodies. 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. CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. YESCARTA, a CD19-directed genetically modified autologous T-cell therapy, became the first CAR-T to be approved for follicular lymphoma by the US FDA in March 2021. Before the approval of YESCARTA, BREYANZI was approved in February 2021 for Grade 3B follicular lymphoma that accounts for about 5-10% of all follicular lymphoma cases. Later in April 2022 it was approved by the European commission. 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 May 2022, Novartis announced that the European Commission approved KYMRIAH (tisagenlecleucel) for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more systemic therapies. 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 May 2022, the US FDA granted approval for KYMRIAH 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. LUNSUMIO became the first bispecific antibody to get approval for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more lines of systemic treatment in June 2022 in Europe. 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. Bispecific antibodies are ready to use therapies and safer treatment options than CAR-Ts. In 2023, LUNSUMIO captured USD 55 million in revenue in the United States for follicular lymphoma. In the United States, AbbVie and Genmab's epcoritamab, marketed as EPKINLY, first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its approval for follicular lymphoma in June 2024. 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. Its strong performance in treating relapsed/refractory DLBCL suggests it could achieve similar success in follicular lymphoma. LUNSUMIO now faces competition in the European market for follicular lymphoma, as on August 19, 2024, the European Commission granted approval for the expanded use of AbbVie and Genmab's bispecific antibody, TEPKINLY (epcoritamab), for treating adults with relapsed/refractory follicular lymphoma. 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, Regeneron's ORDSPONO (odronextamab) a CD20 x CD3 bispecific antibody approved by European Commission on August 26, 2024 for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory DLBCL, after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the first off-the-shelf option that can be administered in the out-patient setting. In March 2024, the US FDA declined approval for odronextamab for treating follicular lymphoma and DLBCL. 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 denial was tied to the enrollment status of confirmatory trials 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 @ Drugs for Follicular Lymphoma Treatment A new class has also emerged for the treatment of follicular lymphoma, i.e., Bruton tyrosine kinase (BTK) inhibitors. In November 2023, BeiGene received approval from the European Commission for BRUKINSA (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 @ New Treatment for Follicular Lymphoma 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 AbbVie's IMBRUVICA, Xynomic Pharmaceuticals' Abexinostat, Pfizer PF-06821497, Incyte's Parsaclisib, Bristol-Myers Squibb's Nivolumab, and others. Discover which therapies are expected to grab major follicular lymphoma market share @ Follicular Lymphoma Market Report IMBRUVICA (ibrutinib) 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. Xynomic Pharmaceuticals is developing Abexinostat 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 fast-track designation 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 @ Follicular Lymphoma Clinical Trials 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 USD 1.4 billion 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 Follicular Lymphoma Market Insight, Epidemiology, and Market Forecast – 2034 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: Total Incident Cases of Follicular Lymphoma Risk-specific Incident Cases of Follicular Lymphoma Stage-specific Incident Cases of Follicular Lymphoma Mutation-specific Incident Cases of Follicular Lymphoma Transplant Eligible and Ineligible Patient Pool of Follicular Lymphoma Refractory/Relapsed Incident Cases of Follicular Lymphoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement 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. Related Reports Follicular Lymphoma Pipeline Follicular Lymphoma Pipeline Insight – 2024 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 Incyte Corporation, Genmab A/S, BeiGene, Merck & Co., ADC Therapeutics, Xynomic Pharmaceuticals, Nordic Nanovector, TG Therapeutics Inc, Allogene Therapeutics, MEI Pharma, Innovent Biologics, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 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 Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 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 Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight 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 . 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Cancer is a big part of Ipsen’s growth strategy, evident in a series of business deals struck by the company in recent years to expand its oncology portfolio and drug pipeline. An Ipsen worker who allegedly profited from stock transactions based on non-public knowledge of his employer’s $247 million buyout of a cancer drug developer has now been charged with insider trading. The Securities and Exchange Commission on Tuesday filed a complaint against Ipsen employee Dishant Gupta. Gupta has agreed to plead guilty, according to a separate court filing. The monetary penalty has yet to be decided. The U.S. Attorney’s Office for the District of Massachusetts has also filed criminal charges against Gupta for his alleged conduct. Paris-based Ipsen maintains U.S. operations in Cambridge, Massachusetts. In early 2022, Ipsen started talking with Epizyme about acquiring that Cambridge-based company’s drug, Tazverik, according to the SEC complaint. Tazverik won FDA approval in 2020 for the treatment of follicular lymphoma. Negotiations between Ipsen and Epizyme progressed from a potential acquisition of the cancer drug to a buyout of the entire biotech company. The Epizyme acquisition was announced on June 27, 2022. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Gupta lives in New Jersey and often worked from home, the SEC said in the complaint. He is director of data strategy and operations, a role that involves the marketing and strategic pricing of products. Through this position, Gupta allegedly learned about the market potential and marketing strategy for a drug that appeared to be Tazverik. In the months leading up to the acquisition announcement, the SEC said Gupta ran numerous internet searches using the phrases “Epizyme buyout” and “Epizyme takeover.” Nine days before the deal was announced, Gupta searched the phrase “Ipsen acquired Epizyme,” according to the complaint. While the companies negotiated the transaction, Gupta allegedly accumulated Epizyme shares. From April to June of 2022, the complaint notes that Gupta purchased Epizyme stock on 27 different days. “While Gupta built a position in Epizyme throughout this period, he was most aggressive in the weeks leading up to the announcement,” the SEC said in the complaint. “Specifically, between June 16, 2022, and June 24, 2022, Gupta purchased approximately 200,000 shares, spending nearly $160,000.” The acquisition announcement came in the early morning hours of June 27, timed to happen ahead of the stock market open in Europe. By 9:30 am Eastern time, Gupta had sold all of his Epizyme shares for a profit of $260,078.27, the SEC said. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum The SEC complaint, filed in the U.S. District Court for the District of Massachusetts, is case number 24-cv-12316. According to a court filing, Gupta has entered a written agreement to plead guilty to one count of securities fraud. He must give up the money he gained illegally and also pay a civil fine. Per terms of the plea, Gupta is barred from serving as am executive or director of any publicly traded company. The terms of this settlement are still subject to court approval. Oncology products are the biggest driver of revenue for Ipsen, accounting for more than €2.3 billion of the company’s €3.1 billion in 2023 sales. Besides the deal that brought the company Tazverik, Ipsen had acquired the approved Merrimack Pharmaceuticals pancreatic cancer drug, Onivyde. the company has also struck deals for programs still in development. In July, Ipsen reached an agreement for global rights to a Phase 1-ready antibody drug conjugate (ADC) from Foreseen Biotechnology. That deal followed the April acquisition of global rights to an ADC from Sutro Biopharma. Ipsen’s oncology interest extends to other types of drugs. In 2022, months after the Epizyme acquisition, Ipsen began a partnership with Marengo Therapeutics focused on the R&D of T cell receptor therapies for cancer.