FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer
FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer
The CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.On Monday, the U.S. Food and Drug Administration issued a complete response letter (CRL) to Johnson & Johnson's (NYSE:JNJ) Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
周一，美国食品和药物管理局向强生（纽交所：JNJ）发出了完整答复信（CRL），涉及其生物制品许可申请，申请内容是用于非小细胞肺癌（NSCLC）且具有表皮生长因子受体（EGFR）突变的患者进行皮下给药的阿米万单抗和重组人透明质酸酶的固定组合（SC阿米万单抗）。
The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility.
该CRL与制造设施标准预批准检查过程中观察到的事项相关。
Also Read: Johnson & Johnson Challenges Government Drug Pricing Dispute Over Two Drugs
另请阅读：强生对政府药品定价争议发起挑战，涉及两种药物。
The CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.
该CRL与产品配方或在监管申请中提交的疗效和安全性数据无关，FDA也没有要求任何额外的临床研究。
The CRL does not impact the currently approved intravenous (IV) formulation of Rybrevant (amivantamab-vmjw).
该CRL不会影响目前已批准的瑞布维特（阿米万单抗-vmjw）的静脉注射（IV）配方。
"We're working closely with the FDA to bring SC amivantamab to patients as quickly as possible and are confident in our path to resolution," said Yusri Elsayed, Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson.
强生的全球治疗领域负责人、肿瘤学创新医学部Yusri Elsayed表示："我们正与FDA密切合作，尽快将SC阿米万单抗提供给患者，并对我们的解决方案充满信心。"
"Backed by interim overall survival data showing a strong favorable trend compared to osimertinib, we believe strongly in the robust efficacy and safety of RYBREVANT — both as a standalone treatment and in combination with LAZCLUZE — for EGFR-mutated advanced lung cancer," Elsayed added.
Elsayed补充道："有临时整体生存数据表明与奥希替尼相比具有强有利趋势，我们坚信瑞布维特的强大疗效和安全性——无论是作为单一疗法还是与LAZCLUZE联合使用——用于EGFR突变的晚期肺癌。"
AstraZeneca Plc (NASDAQ:AZN) sells osimertinib under the Tagrisso name.
阿斯利康（纳斯达克：AZN）以Tagrisso的名称出售奥希替尼。
The BLA is based on the Phase 3 PALOMA-3 study results, presented at the 2024 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
该生物制品申请基于2024年美国临床肿瘤学会年会上发布的第3阶段PALOMA-3研究结果，并已发表在《临床肿瘤学杂志》上。
In August 2024, the FDA granted a Priority Review for the BLA for SC amivantamab as a treatment for patients with NSCLC with EGFR exon 19 deletions or L858R substitution mutations. RYBREVANT is currently approved in over 60 countries worldwide.
在2024年8月，FDA批准了SC amivantamab的生物制品申请的优先审查，作为针对患有EGFR外显子19缺失或L858R替代突变的非小细胞肺癌患者的治疗。RYBREVANt目前在全球超过60个国家获得批准。
JNJ Price Action: Johnson & Johnson stock is up 1.26% at $145.64 at last check Tuesday.
强生股价动态：截至周二最后一次检查，强生股票上涨1.26%，报145.64美元。
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Photo: Shutterstock
Photo: shutterstock
