GlaxoSmithKline LLC

11月25日，葛兰素史克（GSK）宣布，美国FDA已接受其Blenrep (belantamab mafodotin) 的生物制品许可申请 (BLA)，与硼替佐米加地塞米松 (BVd) 和泊马度胺加地塞米松 (BPd) 联合，用于治疗已接受过至少一线治疗的多发性骨髓瘤患者。PDUFA日期为2025年7月23日。 Blenrep是一款治疗多发性骨髓瘤的ADC新药。2020年8月，它顶着“全球首个BCMA靶向疗法”的光环获得美国FDA加速批准，上市当年就为GSK带来近4300万美元的收入。但由于3期确证性试验未达临床试验终点，GSK不得已在2022年11月启动该药在美国的撤市程序。 拓展阅读  押注 ADC 的GSK，能否借Blenrep重整肿瘤业务？| JPM 现在，Blenrep正开启重生之路。 根据GSK新闻稿，此次Blenrep在美国的上市申请基于DREAMM-7和 DREAMM-8的结果。这两项3期试验均达到了主要终点，显示与复发或难治性多发性骨髓瘤的标准治疗相比，Blenrep组合疗法在无进展生存期 (PFS)上具有统计学上显著和临床意义上的改善。两项试验的结果还显示，所有其他次要疗效终点均有临床意义的改善，包括更深度和持久的反应。 在中期分析中，DREAMM-7试验还达到了关键的次要终点——总生存期(OS)，表明Blenrep组合疗法具有统计学上显著且临床上有意义的OS优势。该分析的疗效和安全性数据将于2024年12月9日在即将举行的第66届美国血液学会 (ASH) 年会上公布。 值得一提的是，这也是今年以来，Blenrep组合疗法基于DREAMM-7和 DREAMM-8试验结果递交并获得受理的第六项监管申请。此前，该联合疗法已在欧盟、日本、英国、加拿大和瑞士提交上市申请。在中国，CDE已将Blenrep纳入突破性治疗品种和优先审评，用于与硼替佐米和地塞米松联合治疗既往接受过至少一种治疗的多发性骨髓瘤成年患者。 编辑 | 姚嘉 yao.jia@PharmaDJ.com  总第2233期 访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

Initial pilot study data validate feasibility and applicability of HERC in advancing equitable cancer care delivery at leading cancer centers. MINNEAPOLIS, Oct. 28, 2024 /PRNewswire/ -- Today, the National Comprehensive Cancer Network® (NCCN®) is presenting preliminary data from a study evaluating the usability of the Health Equity Report Card (HERC) tool during the American Public Health Association (APHA) Annual Meeting and Expo. Continue Reading The HERC was created by the Elevating Cancer Equity collaboration between NCCN, the American Cancer Society Cancer Action Network (ACS CAN), and the National Minority Quality Forum (NMQF) and updated by a subsequent working group. It features 19 practice evaluation and change recommendations designed to help providers and healthcare organizations identify and address disparity and bias in care delivery, address social determinants of health, and overcome systemic barriers to optimal care. "[This demonstrates] the HERC's potential as a transformative tool for measuring and improving equity in cancer care." Post this All 19 Health Equity Report Card (HERC) recommendations can be found at NCCN.org/HERC. The study abstract is available at APHA's website at . "Studies clearly show that unequal experiences and opportunities in cancer care result in worse outcomes and shorter life-expectancies for people in underserved communities," stated Taneal D. Carter, MS, MPA, Manager, NCCN Cancer Care Equity Program. "The HERC was initially designed as an objective approach to increase equity in cancer care through attainable and measurable change. This initial pilot study data illustrates just how attainable these goals really are. We are proud to announce that every participating site reported HERC implementation would either inform or reinforce necessary changes in institutional practices and processes." The Health Equity Report Card (HERC) measures care systems' equitable practices across 4 domains: Community Engagement Accessibility of Care and Social Determinants of Health Addressing Bias in Care Delivery Quality and Comprehensiveness of Care The pilot study focused on gathering feedback from five leading academic cancer centers, to gauge the feasibility and usability of the HERC tool. Pre-implementation surveys showed that three of the five cancer centers anticipated challenges in implementing the tool, but all five centers successfully completed a first round of self- and third-party scoring across all domains. Every site strongly agreed or agreed that HERC performance measures, metrics, and sources of evidence were applicable to their institution. "These preliminary findings demonstrate the HERC's usability and underscore its potential as a transformative tool for measuring and improving equity in cancer care," said Crystal S. Denlinger, MD, Chief Executive Officer, NCCN. "We are happy to be able to share this initial data, showcasing how participating sites found the HERC's performance measures to be relevant to their institutions. We look forward to additional analysis of the data and ongoing feedback to further improve the utility of this tool." An article with full results following the first round of scoring—including a subsequent score and improved scorecard—will be publishing in the coming months. Additional evaluation is underway into the HERC's scoring, feedback mechanisms, and impact on cancer care, including a separate pilot project conducted in the community cancer center setting. The HERC pilot program at academic cancer centers is made possible through support from AbbVie Inc.; 2seventy bio; Genentech, Inc.; Lilly; and Sanofi Genzyme. The HERC Community Project is part of the Alliance for Equity in Cancer Care, made possible through support from the Merck Foundation. It is also supported by contributions from Bristol Myers Squibb; GlaxoSmithKline LLC; Lilly; and Pfizer Inc. Visit NCCN.org/equity to learn more about NCCN's ongoing work to improve equity in cancer care. About the National Comprehensive Cancer Network The National Comprehensive Cancer Network® (NCCN ®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information. Media Contact: Rachel Darwin 267-622-6624 [email protected] SOURCE National Comprehensive Cancer Network WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

On August 17, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. Today, the FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic device to select patients with dMMR solid tumors for treatment with dostarlimab-gxly. The efficacy of dostarlimab was evaluated in the GARNET Trial (NCT02715284), a non-randomized, multicenter, open-label, multi-cohort trial. The efficacy population consisted of 209 patients with dMMR recurrent or advanced solid tumors who progressed following systemic therapy and had no satisfactory alternative treatment. The primary efficacy endpoints were overall response rate (ORR) and duration of response (DoR) as determined by blinded independent central review according to RECIST 1.1. The ORR was 41.6% (95% CI: 34.9, 48.6), with 9.1% complete response rate and 32.5% partial response rate. Median DOR was 34.7 months (range 2.6, 35.8+), with 95.4% of patients with duration ≥6 months. Most common adverse reactions (≥20%) in patients with dMMR solid tumors are fatigue /asthenia, anemia, diarrhea, and nausea. Most common Grade 3 or 4 adverse reactions (≥2%) were anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury. Immune-mediated adverse reactions are also associated with dostarlimab-gxly including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and dermatologic toxicity. The recommended dostarlimab dosage is 500 mg every 3 weeks for dose 1 through 4, as an intravenous infusion over 30 minutes. Subsequent dosing beginning 3 weeks after dose 4 is 1,000 mg every 6 weeks. View full prescribing information for Jemperli. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer. Content current as of: 07/18/2023 Regulated Product(s) Drugs 07/18/2023 Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description