/PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto

/PRNewswire/ -- 诺华今天宣布，美国食品药品监督管理局 (FDA) 已批准 Pluvicto

(lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy..

lutetium Lu 177 vipivotide tetraxetan 适用于前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）患者，这些患者已接受过雄激素受体通路抑制剂（ARPI）治疗，并被认为适合延迟化疗。

The expanded indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on results of the Phase III PSMAfore trial. In the study, Pluvicto reduced the risk of radiographic progression or death by 59% (HR=0.41; 95% CI: 0.29, 0.56; p<0.0001) compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy.

基于 III 期 PSMAfore 试验的结果，该扩展适应症大约使符合接受 Pluvicto 治疗条件的患者数量增加了两倍。在研究中，与 PSMA 阳性的 mCRPC 患者在 ARPI 治疗后改用 ARPI 疗法相比，Pluvicto 将影像学进展或死亡的风险降低了 59%（HR=0.41；95% CI：0.29, 0.56；p<0.0001）。

At an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months)*..

在一项更新的探索性分析中，Pluvicto 将中位影像学无进展生存期延长了一倍以上（11.6 个月 vs. 5.6 个月）。

'The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,' said

“Pluvicto 的早期应用指征确实可能改变我们对 mCRPC 患者的治疗模式。与第二种 ARPI 相比，它提供了一种更能延缓疾病进展的靶向治疗。”

Michael Morris

迈克尔·莫里斯

, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and the Principal Investigator of the study in the US. 'This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.'.

，医学博士，纪念斯隆凯特琳癌症中心泌尿肿瘤学前列腺癌科主任，以及该研究在美国的首席研究员。“这一批准是一个重要的进步，应该为接受过一种ARPI治疗但尚未接受化疗的mCRPC患者开启了一扇具有明显临床优势的治疗之门。”

In PSMAfore, the final overall survival (OS) analysis numerically favored Pluvicto, with a hazard ratio of 0.91 (95% CI: 0.72, 1.14), but was not statistically significant. The OS analysis was confounded by the high rate of patients who crossed over from the control arm to Pluvicto (60.3%). When adjusted for crossover, the OS hazard ratio was 0.59 (95% CI: 0.38, 0.91) with the inverse probability of censoring weighting (IPCW) method**..

在PSMAfore中，最终的总生存期（OS）分析在数值上支持Pluvicto，风险比为0.91（95%置信区间：0.72, 1.14），但无统计学显著性。由于从对照组交叉到Pluvicto的患者比例较高（60.3%），OS分析受到了混杂因素的影响。经交叉调整后，使用逆概率删失加权（IPCW）方法得出的OS风险比为0.59（95%置信区间：0.38, 0.91）。

Additional findings from the PSMAfore study showed Pluvicto demonstrated a consistent and favorable safety profile. The most frequently reported all-grade adverse events for Pluvicto were primarily Grade 1-2 and included dry mouth (61%), fatigue (53%), nausea (32%), and constipation (22%). Pluvicto did not impair the ability of patients to be treated with subsequent chemotherapy..

PSMAfore研究的其他结果显示，Pluvicto展示出一致且良好的安全性。Pluvicto最常见的各级不良事件主要为1-2级，包括口干（61%）、疲劳（53%）、恶心（32%）和便秘（22%）。Pluvicto不会影响患者接受后续化疗的能力。

'The clinical development of PSMA-targeting radioligand therapy has provided important insights into the treatment of metastatic castration-resistant prostate cancer,' said

“PSMA靶向放射配体疗法的临床开发为转移性去势抵抗性前列腺癌的治疗提供了重要的见解，”

Oliver Sartor

奥利弗·萨托尔

, MD, Chair of Genitourinary Cancer Disease Group and Director of Radiopharmaceutical Clinical Trials, Mayo Clinic. 'The trial data demonstrated a clear clinical benefit in delaying disease progression in eligible patients, offering an additional therapeutic approach in this setting.'

梅奥诊所泌尿生殖系统癌症疾病组主席兼放射性药物临床试验主任。‘试验数据表明，在符合条件的患者中，延迟疾病进展方面有明显的临床益处，为这一领域提供了额外的治疗途径。’

More than 35,000 men die from prostate cancer each year, and the incidence of the disease is rising.

每年有超过35,000名男性死于前列腺癌，而且该疾病的发病率正在上升。

Half of patients with mCRPC will not live long enough to receive a second treatment.

一半的mCRPC患者活不到接受第二次治疗。

While hormone therapy and chemotherapy are essential treatments for mCRPC, they may not be appropriate for all patients.

虽然激素治疗和化疗是mCRPC的重要治疗方法，但并非所有患者都适用。

Many patients and their healthcare providers prefer to avoid or delay chemotherapy due to side effects, and treatment guidelines recommend avoiding the use of multiple ARPIs.

许多患者及其医疗保健提供者由于副作用而倾向于避免或延迟化疗，治疗指南也建议避免使用多种ARPI。

'With worsening outcomes after each successive line of treatment, patients with this type of metastatic prostate cancer and their families have long faced limited options and uncertain outcomes,' said

“随着每次连续治疗后结果的恶化，这类转移性前列腺癌患者及其家人长期以来面临着有限的选择和不确定的结果，”

Gina Carithers

吉娜·卡里瑟斯

'The now expanded approval of Pluvicto is an empowering development for the prostate cancer community. We now have more choices earlier in the treatment journey, enabling patients to advocate for their preferences and work with their oncologist or urologist to determine the treatment option that best suits their needs.'.

“Pluvicto的批准范围现在扩大，这是前列腺癌领域的一项重要进展。我们现在能够在治疗过程的更早阶段拥有更多选择，使患者能够主张自己的偏好，并与肿瘤科医生或泌尿科医生合作，确定最适合其需求的治疗方案。”

'Today's approval for an expanded indication for Pluvicto brings more choice to nearly three times as many patients, enabling us to further establish radioligand therapies as a pillar in cancer care,' said Victor Bultó, President US, Novartis. 'As pioneers in the RLT space, Novartis is committed to providing education, resources, and practical solutions to healthcare providers to help ensure access for all patients navigating this challenging disease.'.

“今天批准扩大Pluvicto的适应症，使得近三倍的患者有了更多选择，使我们能够进一步确立放射配体疗法作为癌症治疗的支柱，”诺华美国总裁维克多·布托表示。“作为RLT领域的先驱，诺华致力于为医疗保健提供者提供教育、资源和实用解决方案，以帮助确保所有面临这一挑战性疾病的患者都能获得治疗。”

Novartis RLT Patient and Office Support

诺华RLT患者和办公室支持

As the only organization with a dedicated commercial RLT portfolio, we have established a strong infrastructure to ensure patient access and now offer Pluvicto in multiple administration methods, including prefilled syringes. With unparalleled customer experience in the RLT space, Novartis can deliver Pluvicto to the nearly 600 US RLT treatment sites, typically within 5 days to ensure prompt treatment initiation..

作为唯一拥有专门商业化RLT产品组合的机构，我们已经建立了强大的基础设施以确保患者能够获得药物，并且现在提供多种给药方式的Pluvicto，包括预充式注射器。凭借在RLT领域无与伦比的客户体验，诺华能够将Pluvicto快速送至近600个美国RLT治疗中心，通常在5天内送达，以确保及时开始治疗。

Novartis has introduced innovative solutions—including the newly launched RLT Institute—to educate and simplify the integration of RLT into routine clinical practice. The Novartis RLT Institute is an educational platform focused on radiation safety for the setup of treatment sites, equipping site staff with the necessary knowledge to safely administer RLT..

诺华推出了创新的解决方案——包括新成立的RLT研究院——以教育和简化RLT融入常规临床实践的过程。诺华RLT研究院是一个专注于治疗场所设置辐射安全的教育平台，为现场工作人员提供安全实施RLT所需的知识。

Novartis Patient Support is available to help eligible patients get started on treatment, including help understanding insurance coverage and identifying potential financial assistance options. Patients or providers can speak to a live agent at 1-844-638-7222 or visit

诺华患者支持服务可帮助符合条件的患者开始治疗，包括帮助了解保险覆盖范围和识别潜在的财务援助选项。患者或医疗服务提供者可以拨打1-844-638-7222与现场代理交谈，或访问网站。

About Pluvicto

关于Pluvicto

Pluvicto is an intravenous radioligand therapy (RLT) combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein.

Pluvicto 是一种静脉注射的放射配体疗法 (RLT)，它将靶向化合物（配体）与治疗性放射性核素（放射性粒子，此为镥-177）结合在一起。Pluvicto 注入血液后，会与包括表达PSMA（一种跨膜蛋白）的前列腺癌细胞在内的目标细胞结合。

Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death..

一旦结合，放射性同位素发出的能量会损害目标细胞和附近细胞，破坏其复制能力和/或触发细胞死亡。

Based on two Phase III studies, Pluvicto is the only PSMA-targeted agent proven to significantly improve rPFS and demonstrate a safety profile with proven tolerability in both pre- and post-taxane settings for patients with ARPI-treated, PSMA-positive mCRPC. Pluvicto is the first and only targeted radioligand therapy for patients with PSMA-positive mCRPC before the need for chemotherapy.

基于两项III期研究，Pluvicto是唯一被证明可显著改善rPFS，并在ARPI治疗、PSMA阳性的mCRPC患者中，在紫杉烷前和紫杉烷后环境中均显示出安全性和耐受性的PSMA靶向药物。Pluvicto是首个也是唯一针对PSMA阳性mCRPC患者的靶向放射配体疗法，且在需要化疗之前即可使用。

Novartis is investigating Pluvicto in earlier stages of disease, including metastatic hormone-sensitive prostate cancer (PSMAddition, NCT04720157) and oligometastatic prostate cancer (PSMA-DC, NCT05939414).

诺华正在研究Pluvicto在疾病更早期阶段的应用，包括转移性激素敏感性前列腺癌（PSMAddition，NCT04720157）和寡转移性前列腺癌（PSMA-DC，NCT05939414）。

Novartis and Radioligand Therapy (RLT)

诺华与放射性配体疗法 (RLT)

Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation and applying it to advanced cancers, RLT is designed to deliver treatment directly to target cells anywhere in the body.

诺华正在通过RLT为晚期癌症患者重新构想癌症护理。通过利用靶向辐射的力量并将其应用于晚期癌症，RLT旨在将治疗直接递送到体内任何部位的目标细胞。

Novartis is investigating a broad portfolio of RLTs, exploring new isotopes, ligands and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and prostate cancer and into breast, colon, lung and pancreatic cancer. Novartis has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production sites.

诺华正在研究广泛的RLTs组合，探索新的同位素、配体和联合疗法，超越胃肠胰神经内分泌肿瘤（GEP-NETs）和前列腺癌，进入乳腺癌、结肠癌、肺癌和胰腺癌领域。诺华已建立全球专业知识，在其RLT生产站点网络中拥有专业的供应链和制造能力。

To support growing demand for RLTs, we have expanded production capabilities in Millburn, N.J.; Zaragoza, .

为了满足对RLT日益增长的需求，我们已经扩大了新泽西州米尔本和萨拉戈萨的生产能力。

About Novartis

关于诺华

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

诺华是一家创新药物公司。每一天，我们都在努力重新构想药物，以改善和延长人们的生命，使患者、医疗专业人员和社会能够在面对严重疾病时得到支持。我们的药物覆盖全球近3亿人口。