Itacitinib

TAGRISSO has become a standard treatment due to its strong efficacy in both first-line and adjuvant settings. The growing prevalence of EGFR mutations, a rise in lung cancer diagnoses, and broader approvals for early-stage treatment all contribute to its promising growth potential. LAS VEGAS , March 11, 2025 /PRNewswire/ -- DelveInsight's " TAGRISSO Market Size, Forecast, and Market Insight Report" highlights the details around TAGRISSO, a kinase inhibitor of the EGFR, which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately nine-fold lower concentrations than wild-type. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TAGRISSO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. AstraZeneca's TAGRISSO (osimertinib) Overview TAGRISSO is a prescription medication for adults with non-small cell lung cancer (NSCLC) that carries specific EGFR gene mutations. It is used to help prevent cancer recurrence after surgical tumor removal, as a first-line treatment for metastatic NSCLC, or for patients whose cancer has spread and no longer responds to prior EGFR TKI therapy. As a kinase inhibitor, TAGRISSO irreversibly targets specific mutant forms of EGFR (T790M, L858R, and exon 19 deletions) with significantly higher selectivity than the wild-type EGFR. After oral administration, two active metabolites (AZ7550 and AZ5104) circulate at around 10% of the parent drug and exhibit similar inhibitory effects as osimertinib. In vitro studies also show that osimertinib inhibits HER2, HER3, HER4, ACK1, and BLK at clinically relevant levels. The recommended TAGRISSO dosage is 80 mg once daily, taken with or without food, and continued until disease progression or unacceptable toxicity occurs. Learn more about TAGRISSO projected market size for EGFR mNSCLC @ TAGRISSO Market Potential EGFR is a protein that plays a crucial role in cell growth. When mutations occur in the EGFR gene, they can lead to excessive cell growth, potentially causing cancer. These mutations can take various forms, including deletions, insertions, and point mutations. Among the most common EGFR mutations detected in test results are the EGFR exon 19 deletion and the EGFR L858R point mutation. In non-small cell lung cancer, targeted therapies primarily focus on EGFR-sensitizing mutations and EGFR exon 20 insertions. The most frequently observed EGFR mutations include exon 19 deletions and exon 21 L858R mutations. To address these, the FDA has approved several tyrosine kinase inhibitors (TKIs). In 2023, the EGFR-mutated NSCLC market across the 7MM was valued at approximately USD 4 billion. The NSCLC treatment landscape is becoming increasingly biomarker-driven, with EGFR emerging as one of the most lucrative targets. TAGRISSO remains the leading therapy in this segment, maintaining a strong market presence. However, resistance to EGFR TKIs, particularly after TAGRISSO treatment, is a growing challenge. Developing treatments for patients who experience resistance remains one of the most pressing unmet needs in this space. Discover more about the EGFR mNSCLC market in detail @ EGFR Metastatic Non-small Cell Lung Cancer Market Report Emerging Competitors of TAGRISSO The promising candidates in EGFR NSCLC pipeline include Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Zipalertinib (Cullinan Oncology/Taiho Pharma), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Savolitinib (AstraZeneca/Hutchison MediPharma), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), BNT327/PM8002 (Biotheus/BioNTech), Zanidatamab (Jazz Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sasanlimab (Pfizer), Pamvatamig (MCLA-129) (Merus), REQORSA (quaratusugene ozeplasmid) (Genprex), PT-112 (Promontory Therapeutics), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), Carotuximab (ENV-105) (Kairos Pharma), and others. To know more about the number of competing drugs in development, visit @ TAGRISSO Market Positioning Compared to Other Drugs Key Milestones of TAGRISSO In December 2024, TAGRISSO was approved in Europe for patients with unresectable EGFR-mutated lung cancer based on the results of the LAURA Phase III study. In September 2024, TAGRISSO was approved in the US for patients with unresectable stage III EGFR-mutated lung cancer based on LAURA Phase III trial results. In July 2024, TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, was approved in Europe for the first-line treatment of adult patients with advanced EGFR-mutated NSCLC whose tumors have exon 19 deletions or exon 21 (L858R) mutations. Approval was based on the results from the Phase III FLAURA2 study. In June 2024, TAGRISSO in combination with chemotherapy was approved in Japan as a first-line treatment for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In June 2024, TAGRISSO was granted priority review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer. TAGRISSO was also recently granted BTD by the FDA in this setting. In February 2024, TAGRISSO in combination with chemotherapy was approved in the US for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In October 2023, TAGRISSO plus chemotherapy was granted priority review in the US for patients with EGFR-mutated advanced lung cancer based on FLAURA2 Phase III trial results. In August 2022, TAGRISSO was approved in Japan for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the positive results from the global ADAURA Phase III trial. In May 2021, TAGRISSO was approved in Europe for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In December 2020, TAGRISSO was approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In October 2020, TAGRISSO granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the data from the ADAURA Phase III trial. In July 2020, TAGRISSO was granted BTD in the US for the adjuvant treatment of patients with Stage IB–IIIA EGFR-mutated lung cancer based on unprecedented results from the Phase III ADAURA trial. In August 2018, the MHLW approved TAGRISSO for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive NSCLC In June 2018, the EC granted marketing authorization for TAGRISSO as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. In April 2018, the US FDA approved TAGRISSO for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. In April 2018, Molecular Partners and AstraZeneca announced a clinical collaboration for MP0250 in EGFR-mutated NSCLC with osimertinib. Under the collaboration, AstraZeneca will supply osimertinib for the clinical study. In April 2017, the EC granted full marketing authorization for TAGRISSO for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. In March 2017, the US FDA granted full approval for TAGRISSO for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. TAGRISSO was granted accelerated approval for this indication in November 2015 based on tumor response rate and duration of response. In 2017, TAGRISSO was granted BTD and priority review by the US FDA for the first-line treatment of patients with metastatic NSCLC. In March 2016, the MHLW approved TAGRISSO for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR-TKI. In January 2016, AstraZeneca and Incyte Corporation announced a clinical trial collaboration to evaluate the efficacy and safety of INCB39110 in combination with osimertinib. In September 2014, the US FDA granted ODD to TAGRISSO for treating EGFR mutation-positive NSCLC. In April 2014, TAGRISSO received BTD from the US FDA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. In November 2013, TAGRISSO was granted FTD for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. Discover how TAGRISSO is shaping the EGFR NSCLC treatment landscape @ TAGRISSO NSCLC TAGRISSO Market Dynamics TAGRISSO, developed by AstraZeneca, is a third-generation EGFR TKI that has become a key player in the treatment of NSCLC with EGFR mutations. Since its approval, TAGRISSO has gained significant traction due to its efficacy in treating both first-line and post-resistance settings, particularly in patients with the T790M resistance mutation. The drug's ability to penetrate the blood-brain barrier and show strong efficacy against brain metastases has further strengthened its market positioning, leading to widespread adoption among oncologists. A major driver of TAGRISSO's market dynamics is its dominance as the preferred first-line treatment for EGFR-mutated NSCLC. This shift from earlier-generation TKIs has been supported by clinical data demonstrating superior progression-free survival (PFS) and overall survival (OS) benefits. The expansion of TAGRISSO's indications, including its approval in the adjuvant setting for early-stage EGFR-mutated NSCLC, has further broadened its market reach. Additionally, AstraZeneca has aggressively pursued global regulatory approvals, ensuring market access across multiple geographies, particularly in high-prevalence regions such as East Asia, where EGFR mutations are more common. However, TAGRISSO faces growing challenges, including the emergence of resistance mechanisms such as MET amplification and C797S mutations, which limit long-term efficacy. To counteract this, AstraZeneca is exploring combination strategies with MET inhibitors and other targeted therapies. Furthermore, increasing competition from next-generation EGFR TKIs, such as those under development by companies like Takeda and Johnson & Johnson, poses a potential threat. Pricing and reimbursement pressures, particularly in cost-sensitive markets, also impact its commercial strategy, necessitating a balance between pricing optimization and maintaining accessibility. Despite these challenges, TAGRISSO remains a blockbuster drug with robust revenue growth, driven by strong clinical performance and strategic lifecycle management. Ongoing clinical trials evaluating its use in earlier disease stages and in combination therapies could further extend its market leadership. With its strong foothold in the EGFR-mutated NSCLC landscape, TAGRISSO is expected to remain a key driver of AstraZeneca's oncology portfolio in the foreseeable future. Dive deeper to get more insight into TAGRISSO's strengths & weaknesses relative to competitors @ TAGRISSO Market Drug Report Table of Contents Related Reports EGFR Non-small Cell Lung Cancer Market EGFR Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Genentech/Roche, Eli Lilly, Hansoh Pharmaceutical, J&J Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Black Diamond Therapeutic, J INTS BIO, NALO Therapeutics, Scorpion Therapeutics, ORIC Pharmaceuticals, among others. EGFR Non-small Cell Lung Cancer Pipeline EGFR Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key EGFR non-small cell lung cancer companies, including Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

近日，国际血液学领域顶级期刊《Blood》（IF:21.0）刊登了正大天晴自主研发的首创新药（First-in-class）罗伐昔替尼的研究成果，是国产原研创新药在国际舞台的一大突破。作为全球首个进入临床阶段的JAK/ROCK双重小分子抑制剂，罗伐昔替尼在治疗慢性移植物抗宿主病、骨髓纤维化、噬血细胞综合征等疾病中展现出广阔的治疗潜力，目前在国内处于上市审评阶段。 受试者耐受性良好，受累器官均有缓解 异基因造血干细胞移植（HSCT）是治疗恶性血液病的有效方法。慢性移植物抗宿主病（cGVHD）是HSCT后的主要并发症之一，是导致患者长期并发症、非复发死亡、生活质量下降的主要原因，30%-70%的移植受者会受其影响[1-4]。糖皮质激素是cGVHD的一线标准治疗药物，但是这种治疗方案并非对所有cGVHD患者有效，近50%-60%的患者需要在两年内进行二线治疗[5-7]。 此次见刊《Blood》的临床研究，是一项在中国进行的开放标签、多中心的Ib/IIa期临床，主要聚焦于评价罗伐昔替尼治疗糖皮质激素难治性或依赖性慢性移植物抗宿主病的安全性和有效性。 研究共纳入44例中度或重度糖皮质激素难治性或依赖性cGVHD患者，两个剂量组（10mg bid和15mg bid）均未出现剂量限制性毒性，且未发生与罗伐昔替尼相关导致停药的不良事件。研究总体人群的最佳总体缓解率（BOR）为86.4%，两个剂量组之间无差异。其中，BOR在糖皮质激素难治性队列中达到72.7%（8/11），在糖皮质激素依赖性队列中为90.9%（30/33）。无论先前接受过何种治疗，所有受累器官均有缓解表现。在接受罗伐昔替尼治疗的受试者中，12个月无失败生存率（FFS）为85.2%，88.6%的受试者降低了对皮糖皮质激素剂量的需求，59.1%的受试者cGVHD相关症状得到改善。 加速全球临床开发，做行业“排头兵” 首创新药（First-in-class）是指使用全新的、独特的作用机制来治疗某种疾病，在国内外均未上市销售的原创药品。罗伐昔替尼作为全球First-in-class JAK/ROCK双重抑制的小分子抑制剂，通过创新性双重抑制作用，同步阻断异常免疫激活和纤维化进程，在cGVHD患者中表现出更优的临床缓解率。此次研究获《Blood》权威认证，不仅印证了药物的科学价值，更为cGVHD患者提供了全新的治疗选择。 2024年7月，罗伐昔替尼片的上市申请已经获得国家药品监督管理局药品审评中心（CDE）受理，用于治疗中高危骨髓纤维化。2024年10月，正大天晴启动罗伐昔替尼用于治疗中重度cGVHD的Ⅲ期临床试验，2025年1月获得美国食品药品监督管理局（FDA）批准开展cGVHD的Ⅱ期临床试验。正大天晴将加速罗伐昔替尼的全球临床开发，推动产品尽快上市，并致力于开发更多First-in-class创新药物，造福广大患者。 参考文献： [1] 王筱淇,张曦.《慢性移植物抗宿主病(cGVHD)诊断与治疗中国专家共识(2024年版)》解读[J].临床血液学杂志,2024,37(09):597-601. [2] Zeiser R. Novel Approaches to the Treatment of Chronic Graft-Versus-Host Disease. J Clin Oncol 2023; 41(10): 1820-4. [3] Zeiser R, Blazar BR. Acute Graft-versus-Host Disease - Biologic Process, Prevention, and Therapy. N Engl J Med 2017; 377(22): 2167-79. [4] Malard F, Holler E, Sandmaier BM, Huang H, Mohty M. Acute graft-versus-host disease. Nat Rev Dis Primers 2023; 9(1): 27. [5] Miklos DB, Abu Zaid M, Cooney JP, et al. Ibrutinib for First-line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase Ⅲ iNTEGRATE Study[J].Clin Oncol,2023,41(10):1876-887. [6] Zeiser R ,Socie G,Schroeder MA,et al. Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease(GRAVTAS-30l):a randomised,multicentre,double-lind,phase Ⅲ trial[J].Lancet Haematol,2022,9(1):e14-e25. [7] 王筱淇,张曦.《慢性移植物抗宿主病(cGVHD)诊断与治疗中国专家共识(2024年版)》解读[J].临床血液学杂志,2024,37(09):597-601. 声明： 1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2.本公司不对任何药品和/或适应症作推荐。 3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 格索雷塞KRAS G12C精准治疗再传佳音，PFS突破20个月！ ● 正大天晴TQH2722注射液联合背景治疗在季节性过敏性鼻炎II期临床试验招募受试者 ● 关注罕见病，让生命不因“罕见”而孤独 ● “天韵”破局！新研究为血液病合并脓毒症治疗提供关键证据