FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications
正文 · 中文译文
FDA批准amivantamab-vmjw用于EGFR外显子20插入突变非小细胞肺癌适应症 癌症批准 肿瘤（癌症）/血液系统恶性肿瘤批准通知 进行中 | 癌症加速批准 已证实临床获益 | 癌症加速批准 已撤回 | 癌症加速批准 其他 | 癌症加速批准 2024年3月1日，美国食品药品监督管理局（FDA）批准amivantamab-vmjw（Rybrevant，Janssen Biotech，Inc.）联合卡铂和培美曲塞用于经FDA批准的检测方法检测出表皮生长因子受体（EGFR）外显子20插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）的一线治疗。 FDA还授予amivantamab-vmjw传统批准，用于经FDA批准的检测方法检测出EGFR外显子20插入突变、且在含铂化疗期间或之后出现疾病进展的局部晚期或转移性NSCLC成人患者。FDA此前已授予该适应症加速批准。 Rybrevant的完整处方信息将在此处发布。 疗效在PAPILLON（NCT04538664）中进行了评估，该研究是一项随机、开放标签、多中心试验，纳入308例EGFR外显子20插入突变患者。患者按1：1随机接受amivantamab-vmjw联合卡铂和培美曲塞或卡铂和培美曲塞治疗。 主要疗效结局指标为盲态独立中心审查（BICR）评估的无进展生存期（PFS），总生存期（OS）为关键次要结局指标。Amivantamab-vmjw联合卡铂和培美曲塞与卡铂和培美曲塞相比，在PFS方面表现出统计学显著改善，风险比为0.40（95% CI：0.30，0.53；p值<0.0001）。各治疗组的中位PFS分别为11.4个月（95% CI：9.8，13.7）和6.7个月（95% CI：5.6，7.3）。 虽然当前分析时OS结果尚不成熟，仅报告了最终分析预设死亡事件的44%，但未观察到不利趋势。 最常见的不良反应（≥20%）为皮疹、指甲毒性、口腔炎、输注相关反应、疲乏、水肿、便秘、食欲减退、恶心、COVID-19、腹泻和呕吐。 Amivantamab-vmjw的推荐剂量基于体重。具体剂量信息参见处方信息。 本审评在Project Orbis框架下进行，该项目为FDA肿瘤卓越中心的一项倡议。Project Orbis为国际合作伙伴之间肿瘤药物的同步提交和审评提供了框架。本次审评中，FDA与巴西卫生监管局（ANVISA）和加拿大卫生部开展了合作。其他监管机构的申请审评正在进行中。 本综述采用了实时肿瘤学审评（RTOR）试点项目，该项目在完整临床应用提交之前简化了数据提交过程，并采用了评估辅助工具，这是申请人自愿提交以促进FDA评估的工具。FDA比FDA目标日期提前四周批准了该申请。 本申请获得了优先审评。FDA加速项目在《行业指南：严重疾病药物和生物制品的加速项目》中有描述。 医疗保健专业人员应将所有怀疑与任何药物和器械使用相关的严重不良事件报告至FDA的MedWatch报告系统，或致电1-800-FDA-1088。 如需有关研究性肿瘤产品单患者IND的协助，医疗保健专业人员可联系OCE的Project Facilitate，电话240-402-0004，或发送电子邮件至OncProjectFacilitate@fda.hhs.gov。 在X（原Twitter）上关注肿瘤学卓越中心 @FDAOncology。 内容更新日期： 2024年3月1日 受监管产品 药物 肿瘤学
正文 · 英文原文
FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications Cancer Approvals Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals On March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. The FDA also granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA previously granted accelerated approval for this indication. Full prescribing information for Rybrevant will be posted here. Efficacy was evaluated in PAPILLON (NCT04538664), a randomized, open-label multicenter trial of 308 patients with EGFR exon 20 insertion mutations. Patients were randomized 1:1 to receive amivantamab-vmjw with carboplatin and pemetrexed or carboplatin and pemetrexed. The major efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR), with overall survival (OS) as a key secondary outcome measure. Amivantamab-vmjw plus carboplatin and pemetrexed demonstrated a statistically significant improvement in PFS compared with carboplatin and pemetrexed with a hazard ratio of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). The median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms. While OS results were immature at the current analysis, with 44% of pre-specified deaths for the final analysis reported, no trend towards a detriment was observed. The most common adverse reactions (≥20%) were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting. The recommended amivantamab-vmjw dose is based on body weight. See the prescribing information for specific dosage information. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Brazilian Health Regulatory Agency (ANVISA) and Health Canada. The application reviews are ongoing at the other regulatory agencies. This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application four weeks ahead of the FDA goal date. This application was granted priority review. FDA expedited programs are described 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. Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology. Content current as of: 03/01/2024 Regulated Product(s) Drugs Oncology
摘要 待译
On March 1, 2024, the FDAapproved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.